The British Heart Foundation SENIOR-RITA Trial

NSTEMI - Non-ST Segment Elevation MI Clinical Trial

— SENIOR-RITA  

Official title:

The British Heart Foundation Older Patients With Non-ST SEgmeNt elevatIOn myocaRdial Infarction Randomized Interventional TreAtment Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03052036
• Other study ID #: 7910
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2016
• Est. completion date: March 2024

Study information

• Verified date: November 2023
• Source: Newcastle-upon-Tyne Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

SENIOR-RITA is a multicentre prospective open-label trial randomizing patients presenting with type 1 NSTEMI aged ≥75 years between invasive and conservative treatment strategies, to compare time from randomisation to cardiovascular death or non-fatal MI

Description:

The population is getting older and heart artery disease is the biggest killer in the UK. Over recent years, there have been improvements in medications and technologies to treat it, but these have been primarily tested in younger patients. Previous research studies suggest that older patients (75 years and over) are not well represented in clinical research and these patients in particular those that are frail and those with co-morbidities are less likely to receive advanced medications and medical procedures. The current study will enrol patients 75 years and over, presenting with a heart attack. If patients agree to participate, they will be randomly allocated to one of two treatment groups. In the first group, patients will receive the latest medications recommended in heart attack. In the second group, in addition to these medications, patients will have coronary angiography. This will show whether they have any blockages in heart arteries. If appropriate, coronary revascularisation by percutaneous coronary intervention (PCI) commonly known as coronary angioplasty or coronary artery bypass grafting, sometimes called CABG (a surgical procedure in which a blood vessel from the leg, arm or chest is used to bypass a narrowed section of a coronary artery) will be carried out. During the trial, frailty scores, cognition measures, co-morbidity indices, questionnaires on quality of life, NHS and personal social services utilization will be collected from the participant and in addition proxy quality of life information will be collected from the participant's carers. Investigators will evaluate which one of the two treatment groups will do better and live longer. Investigators will also collect information on their quality of life and frailty measures for a 5 year period. The trial hopes to recruit 2300 patients from approximately 30 centres across the UK.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1518
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

Inclusion Criteria:

• Aged = 75 years

• Type 1 NSTEMI during index hospitalisation

Exclusion Criteria:

• Patients presenting with STEMI or unstable angina

• Patients with cardiogenic shock

• Patients with known life expectancy <1 year

• Patients in whom neither the patient nor the consultee are able and willing to provide written informed consent

• Previous inclusion in the BHF SENIOR-RITA trial

• Inability to undergo invasive coronary angiography, such as no vascular access site, or absolute contraindication to coronary revascularisation

Related Conditions & MeSH terms

• NSTEMI - Non-ST Segment Elevation MI

Intervention

Procedure:
• Coronary Angiography
Coronary angiography to determine location of blocked or narrowed arteries.
• Coronary revascularisation
PCI or CABG will be performed following coronary angiography at the discretion of the treating cardiologist.

Other:
• Optimal Medical Therapy
Patients to receive conservative treatment in the form of guideline recommended secondary prevention therapy including antiplatelet therapy, statins, ACE Inhibitors and beta blockers.

Locations

Country	Name	City	State
United Kingdom	Aberdeen Royal Infirmary	Aberdeen
United Kingdom	Basildon & Thurrock University Hospitals NHS Foundation Trust	Basildon
United Kingdom	Blackpool Teaching Hospitals NHS Foundation Trust	Blackpool
United Kingdom	Bradford Teaching Hospitals NHS Foundation Trust	Bradford
United Kingdom	Broomfield Hospital, Mid Essex Hospitals NHS Trust	Broomfield
United Kingdom	Cumberland Infirmary, North Cumbria University Hospitals NHS Trust	Carlisle
United Kingdom	St Helier Hospital, Epsom & St Helier University Hospitals NHS Trust	Carshalton
United Kingdom	Chesterfield Royal Hospital NHS Foundation Trust	Chesterfield
United Kingdom	County Durham & Darlington NHS Foundation Trust	Darlington
United Kingdom	Royal Derby Hospital, Derby Teaching Hospitals NHS Foundation Trust	Derby,
United Kingdom	Ninewells Hospital, NHS Tayside	Dundee
United Kingdom	Lanarkshire East Kilbride NHS Foundation Trust	East Kilbride
United Kingdom	East Sussex NHS Healthcare Trust	Eastbourne
United Kingdom	Royal Infirmary of Edinburgh	Edinburgh
United Kingdom	Gateshead Hospitals NHS Foundation Trust	Gateshead
United Kingdom	Queen Elizabeth University Hospital	Glasgow
United Kingdom	Royal Alexandra Hospital	Glasgow
United Kingdom	North Tees and Hartlepool Foundation Trust	Hartlepool
United Kingdom	NHS Ayrshire & Arran	Kilmarnock
United Kingdom	Leeds General Infirmary	Leeds
United Kingdom	United Lincolnshire Healthcare Trust	Lincoln
United Kingdom	Chelsea and Westminster	London
United Kingdom	Hammersmith Hospital, Imperial College Healthcare NHS Trust	London
United Kingdom	London Royal Free, Royal Free London NHS Foundation Trust	London
United Kingdom	Wythenshawe Hospital, University Hospital of South Manchester NHS Foundation Trust	Manchester
United Kingdom	Borders General Hospital	Melrose
United Kingdom	South Tees NHS Foundation Trust	Middlesbrough
United Kingdom	The Newcastle Upon Tyne Hospital NHS Foundation Trust	Newcastle upon Tyne
United Kingdom	Northumbria Healthcare NHS Foundation Trust	North Shields
United Kingdom	Pennine Acute Hospitals NHS Trust	Oldham
United Kingdom	Plymouth Hospital, Plymouth Hospitals NHS Trust	Plymouth
United Kingdom	Royal Berkshire Hospital, Royal Berkshire Foundation NHS Trust	Reading
United Kingdom	East Surrey Hospital, Surrey & Sussex NHS Trust	Redhill
United Kingdom	Salford Royal NHS Foundation Trust	Salford
United Kingdom	Sheffield Teaching Hospitals NHS Foundation Trust	Sheffield
United Kingdom	South Tyneside NHS Foundation Trust	South Shields
United Kingdom	City Hospitals Sunderland NHS Foundation Trust	Sunderland
United Kingdom	Torbay Hospital, Torbay & South Devon NHS Foundation Trust	Torquay
United Kingdom	Pinderfields General Hospital	Wakefield	West Yorkshire
United Kingdom	The York Hospital, York Teaching Hospital NHS Foundation Trust	York

Sponsors (3)

Lead Sponsor	Collaborator
Newcastle-upon-Tyne Hospitals NHS Trust	British Heart Foundation, Newcastle University

Country where clinical trial is conducted

United Kingdom, 

References & Publications (38)

Alexander KP, Newby LK, Cannon CP, Armstrong PW, Gibler WB, Rich MW, Van de Werf F, White HD, Weaver WD, Naylor MD, Gore JM, Krumholz HM, Ohman EM; American Heart Association Council on Clinical Cardiology; Society of Geriatric Cardiology. Acute coronary — View Citation

Alter DA, Manuel DG, Gunraj N, Anderson G, Naylor CD, Laupacis A. Age, risk-benefit trade-offs, and the projected effects of evidence-based therapies. Am J Med. 2004 Apr 15;116(8):540-5. doi: 10.1016/j.amjmed.2003.10.039. — View Citation

Avezum A, Makdisse M, Spencer F, Gore JM, Fox KA, Montalescot G, Eagle KA, White K, Mehta RH, Knobel E, Collet JP; GRACE Investigators. Impact of age on management and outcome of acute coronary syndrome: observations from the Global Registry of Acute Coro — View Citation

Bagnall AJ, Goodman SG, Fox KA, Yan RT, Gore JM, Cheema AN, Huynh T, Chauret D, Fitchett DH, Langer A, Yan AT; Canadian Acute Coronary Syndrome Registry I and II Investigators; Canadian Global Registry of Acute Coronary Events (GRACE/GRACE2) Investigators — View Citation

Bauer T, Koeth O, Junger C, Heer T, Wienbergen H, Gitt A, Zahn R, Senges J, Zeymer U; Acute Coronary Syndromes Registry (ACOS) Investigators. Effect of an invasive strategy on in-hospital outcome in elderly patients with non-ST-elevation myocardial infarc — View Citation

Beecham J KM. Costing psychiatric interventions. In: Thornicroft, graham, ed. Measuring mental health needs (second edition). Royal college of psychiatrists, london, 2001, 200-224. Measuring Mental Health Needs 2001;Second Edition 24

Caro JJ, Briggs AH, Siebert U, Kuntz KM; ISPOR-SMDM Modeling Good Research Practices Task Force. Modeling good research practices--overview: a report of the ISPOR-SMDM Modeling Good Research Practices Task Force--1. Value Health. 2012 Sep-Oct;15(6):796-80 — View Citation

Chait R, Zad O, Ramineni R, Shukla A, Mitchell A. Midterm outcomes and quality of life following percutaneous coronary intervention in nonagenarians. Am J Cardiol. 2011 Jun 1;107(11):1609-12. doi: 10.1016/j.amjcard.2011.01.046. Epub 2011 Mar 21. — View Citation

Devlin G, Gore JM, Elliott J, Wijesinghe N, Eagle KA, Avezum A, Huang W, Brieger D; GRACE Investigators. Management and 6-month outcomes in elderly and very elderly patients with high-risk non-ST-elevation acute coronary syndromes: The Global Registry of — View Citation

Ekerstad N, Swahn E, Janzon M, Alfredsson J, Lofmark R, Lindenberger M, Andersson D, Carlsson P. Frailty is independently associated with 1-year mortality for elderly patients with non-ST-segment elevation myocardial infarction. Eur J Prev Cardiol. 2014 O — View Citation

Ekerstad N, Swahn E, Janzon M, Alfredsson J, Lofmark R, Lindenberger M, Carlsson P. Frailty is independently associated with short-term outcomes for elderly patients with non-ST-segment elevation myocardial infarction. Circulation. 2011 Nov 29;124(22):239 — View Citation

Fox KA, Anderson FA Jr, Dabbous OH, Steg PG, Lopez-Sendon J, Van de Werf F, Budaj A, Gurfinkel EP, Goodman SG, Brieger D; GRACE investigators. Intervention in acute coronary syndromes: do patients undergo intervention on the basis of their risk characteri — View Citation

Fox KA, Clayton TC, Damman P, Pocock SJ, de Winter RJ, Tijssen JG, Lagerqvist B, Wallentin L; FIR Collaboration. Long-term outcome of a routine versus selective invasive strategy in patients with non-ST-segment elevation acute coronary syndrome a meta-ana — View Citation

Fox KA, Poole-Wilson PA, Henderson RA, Clayton TC, Chamberlain DA, Shaw TR, Wheatley DJ, Pocock SJ; Randomized Intervention Trial of unstable Angina Investigators. Interventional versus conservative treatment for patients with unstable angina or non-ST-el — View Citation

Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. — View Citation

Goodman SG, Huang W, Yan AT, Budaj A, Kennelly BM, Gore JM, Fox KA, Goldberg RJ, Anderson FA Jr; Expanded Global Registry of Acute Coronary Events (GRACE2) Investigators. The expanded Global Registry of Acute Coronary Events: baseline characteristics, man — View Citation

Granger CB, Goldberg RJ, Dabbous O, Pieper KS, Eagle KA, Cannon CP, Van De Werf F, Avezum A, Goodman SG, Flather MD, Fox KA; Global Registry of Acute Coronary Events Investigators. Predictors of hospital mortality in the global registry of acute coronary — View Citation

Hochman JS, Sleeper LA, Webb JG, Sanborn TA, White HD, Talley JD, Buller CE, Jacobs AK, Slater JN, Col J, McKinlay SM, LeJemtel TH. Early revascularization in acute myocardial infarction complicated by cardiogenic shock. SHOCK Investigators. Should We Eme — View Citation

Hordijk-Trion M, Lenzen M, Wijns W, de Jaegere P, Simoons ML, Scholte op Reimer WJ, Bertrand ME, Mercado N, Boersma E; EHS-CR Investigators. Patients enrolled in coronary intervention trials are not representative of patients in clinical practice: results — View Citation

Kandzari DE, Roe MT, Chen AY, Lytle BL, Pollack CV Jr, Harrington RA, Ohman EM, Gibler WB, Peterson ED. Influence of clinical trial enrollment on the quality of care and outcomes for patients with non-ST-segment elevation acute coronary syndromes. Am Hear — View Citation

Lee PY, Alexander KP, Hammill BG, Pasquali SK, Peterson ED. Representation of elderly persons and women in published randomized trials of acute coronary syndromes. JAMA. 2001 Aug 8;286(6):708-13. doi: 10.1001/jama.286.6.708. — View Citation

Machin D, Campbell MJ, Tan SB, Tan SH. Comparing survival curves. Sample size tables for clinical studies. Wiley-Blackwell; 2009:84-101.

Nguyen HL, Goldberg RJ, Gore JM, Fox KA, Eagle KA, Gurfinkel EP, Spencer FA, Reed G, Quill A, Anderson FA Jr. Age and sex differences, and changing trends, in the use of evidence-based therapies in acute coronary syndromes: perspectives from a multination — View Citation

Orimo H, Ito H, Suzuki T, Araki A, Hosoi T, Sawabe M. Reviewing the definition of "elderly". Geriatrics & Gerontology International. 2006;6:149-158

Patel A, Rendu A, Moran P, Leese M, Mann A, Knapp M. A comparison of two methods of collecting economic data in primary care. Fam Pract. 2005 Jun;22(3):323-7. doi: 10.1093/fampra/cmi027. Epub 2005 Apr 11. — View Citation

Pfisterer M, Buser P, Osswald S, Allemann U, Amann W, Angehrn W, Eeckhout E, Erne P, Estlinbaum W, Kuster G, Moccetti T, Naegeli B, Rickenbacher P; Trial of Invasive versus Medical therapy in Elderly patients (TIME) Investigators. Outcome of elderly patie — View Citation

Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A. A global clinical measure of fitness and frailty in elderly people. CMAJ. 2005 Aug 30;173(5):489-95. doi: 10.1503/cmaj.050051. — View Citation

Sacco RL, Kasner SE, Broderick JP, Caplan LR, Connors JJ, Culebras A, Elkind MS, George MG, Hamdan AD, Higashida RT, Hoh BL, Janis LS, Kase CS, Kleindorfer DO, Lee JM, Moseley ME, Peterson ED, Turan TN, Valderrama AL, Vinters HV; American Heart Associatio — View Citation

Savonitto S, Cavallini C, Petronio AS, Murena E, Antonicelli R, Sacco A, Steffenino G, Bonechi F, Mossuti E, Manari A, Tolaro S, Toso A, Daniotti A, Piscione F, Morici N, Cesana BM, Jori MC, De Servi S; Italian Elderly ACS Trial Investigators. Early aggre — View Citation

Seto TB, Taira DA, Berezin R, Chauhan MS, Cutlip DE, Ho KK, Kuntz RE, Cohen DJ. Percutaneous coronary revascularization in elderly patients: impact on functional status and quality of life. Ann Intern Med. 2000 Jun 20;132(12):955-8. doi: 10.7326/0003-4819 — View Citation

Sinclair H, Kunadian V. Coronary revascularisation in older patients with non-ST elevation acute coronary syndromes. Heart. 2016 Mar;102(6):416-24. doi: 10.1136/heartjnl-2015-307859. Epub 2016 Jan 6. — View Citation

Tegn N, Abdelnoor M, Aaberge L, Endresen K, Smith P, Aakhus S, Gjertsen E, Dahl-Hofseth O, Ranhoff AH, Gullestad L, Bendz B; After Eighty study investigators. Invasive versus conservative strategy in patients aged 80 years or older with non-ST-elevation m — View Citation

Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD; Writing Group on the Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction; Thygesen K, Alpert JS, White HD, Jaffe AS, Katus HA, Apple FS, Lindahl B, Mor — View Citation

Tinetti ME, Bogardus ST Jr, Agostini JV. Potential pitfalls of disease-specific guidelines for patients with multiple conditions. N Engl J Med. 2004 Dec 30;351(27):2870-4. doi: 10.1056/NEJMsb042458. No abstract available. — View Citation

Townsend N, Wickramasinghe K, Bhatnagar P, Smolina K, Nichols M, Leal J, Luengo-Fernandez R, Rayner M. Coronary heart disease statistics 2012 edition. 2012

TRIUMPH Investigators; Alexander JH, Reynolds HR, Stebbins AL, Dzavik V, Harrington RA, Van de Werf F, Hochman JS. Effect of tilarginine acetate in patients with acute myocardial infarction and cardiogenic shock: the TRIUMPH randomized controlled trial. J — View Citation

Veerasamy M, Edwards R, Ford G, Kirkwood T, Newton J, Jones D, Kunadian V. Acute coronary syndrome among older patients: a review. Cardiol Rev. 2015 Jan-Feb;23(1):26-32. doi: 10.1097/CRD.0000000000000016. — View Citation

Zaman MJ, Stirling S, Shepstone L, Ryding A, Flather M, Bachmann M, Myint PK. The association between older age and receipt of care and outcomes in patients with acute coronary syndromes: a cohort study of the Myocardial Ischaemia National Audit Project (MINAP). Eur Heart J. 2014 Jun 14;35(23):1551-8. doi: 10.1093/eurheartj/ehu039. Epub 2014 Mar 18. — View Citation

* Note: There are 38 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to cardiovascular death or non-fatal MI (defined by the third universal definition) from randomization	To determine the impact of a routine invasive strategy on cardiovascular death and non-fatal myocardial infarction (MI) compared with a conservative treatment strategy in older patients (=75 years) with NSTEMI.	Up to 5 years
Secondary	All cause, cardiovascular and non-cardiovascular death rates		Up to 5 years
Secondary	Recurrent myocardial infarction		Up to 5 years
Secondary	Hospitalisation for heart failure		Up to 5 years
Secondary	Urgent coronary revascularisation		Up to 5 years
Secondary	Recurrent hospitalisation for myocardial infarction		Up to 5 years
Secondary	Stroke		Up to 5 years
Secondary	Length of time spent at home		Up to 5 years
Secondary	Fried and Rockwood frailty scores		Up to 5 years
Secondary	Quality of Life using EQ-5D-5L and quality adjusted life years (QALY)	Quality of life will be measured using the EQ-5D-5L instrument[REF: The EuroQol Group (1990). EuroQol-a new facility for the measurement of health-related quality of life. Health Policy 16(3):199-208html ] (paper and telephone versions), with the results for each participant converted into quality-adjusted life-years (QALYs) using the area under the curve approach, a standard methodology for this process,[REF: Drummond MOB, B; Stoddart, G; Torrance, G. . Methods for the economic evaluation of Health Care Programmes: Oxford University Press 2005.] with the responses to the EQ-5D-5L scored using the appropriate value set for the United Kingdom, which is expected to be available by the time of the analysis. REF: Office for Health Economics. New OHE Publications: An EQ-5D-5L Value Set for England. Available at: https://www.ohe.org/news/new-ohe-publications-eq-5d-5l-value-set-england. Accessed February 03 2017]	Up to 5 years
Secondary	Costs to the NHS and personal social services		Up to 5 years
Secondary	Incremental cost per QALY gained at 1 year		Up to 5 years
Secondary	Procedural complications	Perforation, myocardial infarction (Type 4a), coronary dissection, TIA, Death in Cath Lab, Aortic dissection	Within 7 days of invasive care
Secondary	Bleeding	Bleeding according to BARC Criteria	Up to 1 year
Secondary	Renal replacement therapy	Need for renal replacement therapy	Within 7 days of invasive care
Secondary	25% increase in serum creatinine concentration	25% increase in serum creatinine concentration from baseline (hospitalisation)	Within 7 days of invasive care

External Links

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