Scottish COmputed Tomography of the HEART Trial

Coronary Heart Disease Clinical Trial

— SCOT-HEART  

Official title:

Role of Multidetector Computed Tomography in the Diagnosis and Management of Patients Attending a Rapid Access Chest Pain Clinic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01149590
• Other study ID #: CZH/4/588
• Status: Completed
• Phase: N/A
• Start date: November 2010
• Est. completion date: May 2015

Study information

• Verified date: April 2017
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of the study is to see if coronary artery calcium score and computed tomography coronary angiogram alters the proportion of patients diagnosed with angina due to coronary heart disease.

Description:

Rapid access chest pain clinics have facilitated the early diagnosis and treatment of patients with coronary heart disease and angina. Despite this important service provision, coronary heart disease continues to be under-diagnosed and many patients are left untreated and at risk. Recent advances in imaging technology have now led to the widespread use of non-invasive computed tomography both to measure coronary artery calcium scores and undertake coronary angiography. However, this technology has not been robustly evaluated in any systematic approach. Using state-of-the-art multidetector computed tomography scanners, we propose to undertake a major multicentre randomized controlled trial to assess the added value of computed tomography imaging in over 4000 patients attending rapid access chest pain clinics across Scotland. This will define the most appropriate use of this emerging technology in the setting of diagnosing and treating patients with coronary heart disease and angina pectoris. This study will also lay the foundation for future studies to look at the potential prognostic value of this technology.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4138
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 18 and =75 years of age

• Attendance at the Rapid Access Chest Pain Clinic

Exclusion Criteria:

• Inability or unwilling to undergo computed tomography scanning, such as exceeding weight tolerance of scanner

• Severe renal failure (serum creatinine >200 µmol/L or estimated glomerular filtration rate <30 mL/min)

• Previous recruitment to the trial

• Major allergy to iodinated contrast agent

• Unable to give informed consent

• Known pregnancy

• Acute coronary syndrome within 3 months

Related Conditions & MeSH terms

• Angina Pectoris
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Procedure:
• Computer Tomography Angiography
Computed Tomography Angiography

Locations

Country	Name	City	State
United Kingdom	University Hospital Ayr	Ayr
United Kingdom	Ninewells Hospital	Dundee	Tayside
United Kingdom	Royal Infirmary Edinburgh	Edinburgh
United Kingdom	Western General Hospital	Edinburgh
United Kingdom	Glasgow Royal Infirmary	Glasgow
United Kingdom	Western Infirmary Glasgow	Glasgow
United Kingdom	Victoria Hospital	Kirkcaldy	Fife
United Kingdom	Forth Valley Royal	Larbert
United Kingdom	St John's Hosptial	Livingston
United Kingdom	Borders General Hospital	Melrose	Borders
United Kingdom	Royal Alexandra Hospital	Paisley
United Kingdom	Perth Royal Infirmary	Perth

Sponsors (3)

Lead Sponsor	Collaborator
University of Edinburgh	Chief Scientist Office of the Scottish Government, NHS Lothian

Country where clinical trial is conducted

United Kingdom, 

References & Publications (3)

Newby DE, Williams MC, Flapan AD, Forbes JF, Hargreaves AD, Leslie SJ, Lewis SC, McKillop G, McLean S, Reid JH, Sprat JC, Uren NG, van Beek EJ, Boon NA, Clark L, Craig P, Flather MD, McCormack C, Roditi G, Timmis AD, Krishan A, Donaldson G, Fotheringham M, Hall FJ, Neary P, Cram L, Perkins S, Taylor F, Eteiba H, Rae AP, Robb K, Barrie D, Bissett K, Dawson A, Dundas S, Fogarty Y, Ramkumar PG, Houston GJ, Letham D, O'Neill L, Pringle SD, Ritchie V, Sudarshan T, Weir-McCall J, Cormack A, Findlay IN, Hood S, Murphy C, Peat E, Allen B, Baird A, Bertram D, Brian D, Cowan A, Cruden NL, Dweck MR, Flint L, Fyfe S, Keanie C, MacGillivray TJ, Maclachlan DS, MacLeod M, Mirsadraee S, Morrison A, Mills NL, Minns FC, Phillips A, Queripel LJ, Weir NW, Bett F, Divers F, Fairley K, Jacob AJ, Keegan E, White T, Gemmill J, Henry M, McGowan J, Dinnel L, Francis CM, Sandeman D, Yerramasu A, Berry C, Boylan H, Brown A, Duffy K, Frood A, Johnstone J, Lanaghan K, MacDuff R, MacLeod M, McGlynn D, McMillan N, Murdoch L, Noble C, Paterson V, Steedman T, Tzemos N. Role of multidetector computed tomography in the diagnosis and management of patients attending the rapid access chest pain clinic, The Scottish computed tomography of the heart (SCOT-HEART) trial: study protocol for randomized controlled trial. Trials. 2012 Oct 4;13:184. doi: 10.1186/1745-6215-13-184. — View Citation

SCOT-HEART investigators. CT coronary angiography in patients with suspected angina due to coronary heart disease (SCOT-HEART): an open-label, parallel-group, multicentre trial. Lancet. 2015 Jun 13;385(9985):2383-91. doi: 10.1016/S0140-6736(15)60291-4. Ep — View Citation

SCOT-HEART Investigators; Newby DE, Adamson PD, Berry C, Boon NA, Dweck MR, Flather M, Forbes J, Hunter A, Lewis S, MacLean S, Mills NL, Norrie J, Roditi G, Shah ASV, Timmis AD, van Beek EJR, Williams MC. Coronary CT Angiography and 5-Year Risk of Myocard — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients diagnosed with angina pectoris secondary to coronary heart disease		6 weeks
Secondary	Symptoms	(i) Chest pain. (ii) Quality of life.	Baseline, after computed tomography scan (where appropriate), 6 weeks and 6 months
Secondary	Diagnosis	(i) Diagnosis and severity of coronary heart disease (ii) Accuracy of computed tomography coronary angiography	Baseline, after computed tomography scan (where appropriate), 6 weeks and 6 months
Secondary	Investigations	(i) Exercise electrocardiographic stress test (ii) Nuclear medicine imaging - myocardial perfusion imaging (iii) Stress echocardiography (iv) Invasive coronary angiography (v) Non-coronary investigations	Baseline, 6 weeks, 6 months
Secondary	Treatment	(i) Secondary prevention (ii) Pharmacological anti-anginal therapy (iii) Coronary revascularisation	Baseline, after computed tomography scan (where appropriate), 6 weeks, 6 months
Secondary	Long-term outcome	(i) Coronary heart disease death or non-fatal Myocardial Infarction (MI) (ii) Coronary heart disease death (iii) Non-fatal MI (iv) Coronary heart disease death, non-fatal MI or non-fatal stroke (v) Non-fatal stroke (vi) All-cause death (vii) Cardiovascular death (viii) Coronary revascularisation; percutaneous coronary intervention or coronary artery bypass graft surgery (ix) Hospitalisation for chest pain including acute coronary syndromes and non-coronary chest pain (x) Hospitalisation for cardiovascular disease including coronary artery disease, cerebrovascular disease and peripheral arterial disease	10 years