Telemedicine in High-Risk Cardiovascular Patients Post-ACS

Cardiovascular Diseases Clinical Trial

— TELE-ACS  

Official title:

Remote Acute Assessment of Patients With High Cardiovascular Risk Post-Acute Coronary Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05015634
• Other study ID #: 21HH7034
• Status: Recruiting
• Phase: N/A
• Start date: January 6, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2023
• Source: Imperial College London
• Contact: Ramzi Y Khamis, MB ChB PhD FRCP
• Phone: 02075946842
• Email: r.khamis[@]imperial.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a non-CTIMP randomised controlled trial looking at the utilisation of telemedicine devices to provide remote, clinically necessary, diagnostic information, without the need for hospital attendance that patients will take home with them following admission to hospital with a heart attack.

Description:

Following hospital admission with a heart attack, telemedicine equipment can provide patients with remote, clinically necessary diagnostic information without the need for hospital attendance, which they can take home when they discharge from the hospital. In this project, patients known to be at high risk of ACS are equipped and empowered to seek urgent medical attention without visiting the hospital, if they experience symptoms, and to determine whether or not to seek emergency treatment, with an immediate remote specialist consultation, as assessed by validated technology.

Those enrolled in the intervention group will be offered telemedicine packages upon discharge from the hospital. Those enrolled in the active arm will have their telemedicine package provided to the trial team when they conduct an ECG and seek medical attention. In contrast, in the control group, routine clinical care will be provided, as well as follow up by phone over 9 months.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 338
• Est. completion date: December 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 1 ACS Patients diagnosed with elevated hs-cTnI I who have undergone coronary intervention for NSTEMI or STEMI or unstable angina.

• 2 In addition, the participant should have at least one additional cardiovascular risk factor:

• Current or ex-Tobacco Use

• Hypertension

• Diabetes

• Hypercholesterolaemia.

• Male aged > 50 years.

• 3 Access to a smartphone or smart device.

Exclusion Criteria:

• 1 The inability to apply/use the telemonitoring equipmentt

• 2 Life expectancy of 9 months or less.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Cardiovascular Diseases
• Syndrome

Intervention

Other:
• Active Arm
Patient develops possible cardiac symptoms, takes an ECG, BP and oxygen saturation as per their training. Patient will receive a phone call by the trial cardiologist who will have access to a high-quality ECG trace, as well as blood pressure and oxygen saturations, and coupled with the clinical history, can decide on the most appropriate course of further management. With remote follow up over the phone at 3, 6 and 9 months.
• Control Arm
Standard routine clinical care will be carried out, with remote follow up over the phone at 3, 6 and 9 months.

Locations

Country	Name	City	State
United Kingdom	Imperial College Healthcare NHS Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
Imperial College London	King Khalid University

Country where clinical trial is conducted

United Kingdom, 

References & Publications (8)

Ben-Assa E, Shacham Y, Golovner M, Malov N, Leshem-Rubinow E, Zatelman A, Oren Shamir A, Rogowski O, Roth A. Is telemedicine an answer to reducing 30-day readmission rates post-acute myocardial infarction? Telemed J E Health. 2014 Sep;20(9):816-21. doi: 10.1089/tmj.2013.0346. Epub 2014 Jul 21. — View Citation

Dreyer RP, Dharmarajan K, Kennedy KF, Jones PG, Vaccarino V, Murugiah K, Nuti SV, Smolderen KG, Buchanan DM, Spertus JA, Krumholz HM. Sex Differences in 1-Year All-Cause Rehospitalization in Patients After Acute Myocardial Infarction: A Prospective Observational Study. Circulation. 2017 Feb 7;135(6):521-531. doi: 10.1161/CIRCULATIONAHA.116.024993. — View Citation

Garcia S, Albaghdadi MS, Meraj PM, Schmidt C, Garberich R, Jaffer FA, Dixon S, Rade JJ, Tannenbaum M, Chambers J, Huang PP, Henry TD. Reduction in ST-Segment Elevation Cardiac Catheterization Laboratory Activations in the United States During COVID-19 Pandemic. J Am Coll Cardiol. 2020 Jun 9;75(22):2871-2872. doi: 10.1016/j.jacc.2020.04.011. Epub 2020 Apr 10. No abstract available. — View Citation

Khera R, Wang Y, Bernheim SM, Lin Z, Krumholz HM. Post-discharge acute care and outcomes following readmission reduction initiatives: national retrospective cohort study of Medicare beneficiaries in the United States. BMJ. 2020 Jan 15;368:l6831. doi: 10.1136/bmj.l6831. — View Citation

Kwok CS, Wong CW, Shufflebotham H, Brindley L, Fatima T, Shufflebotham A, Barker D, Pawala A, Heatlie G, Mamas MA. Early Readmissions After Acute Myocardial Infarction. Am J Cardiol. 2017 Sep 1;120(5):723-728. doi: 10.1016/j.amjcard.2017.05.049. Epub 2017 Jun 15. — View Citation

Marijon E, Karam N, Jost D, Perrot D, Frattini B, Derkenne C, Sharifzadehgan A, Waldmann V, Beganton F, Narayanan K, Lafont A, Bougouin W, Jouven X. Out-of-hospital cardiac arrest during the COVID-19 pandemic in Paris, France: a population-based, observational study. Lancet Public Health. 2020 Aug;5(8):e437-e443. doi: 10.1016/S2468-2667(20)30117-1. Epub 2020 May 27. — View Citation

Southern DA, Ngo J, Martin BJ, Galbraith PD, Knudtson ML, Ghali WA, James MT, Wilton SB. Characterizing types of readmission after acute coronary syndrome hospitalization: implications for quality reporting. J Am Heart Assoc. 2014 Sep 18;3(5):e001046. doi: 10.1161/JAHA.114.001046. — View Citation

Wang H, Zhao T, Wei X, Lu H, Lin X. The prevalence of 30-day readmission after acute myocardial infarction: A systematic review and meta-analysis. Clin Cardiol. 2019 Oct;42(10):889-898. doi: 10.1002/clc.23238. Epub 2019 Aug 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All hospital readmission rates	At 6 months of follow up, compare formal admissions and not emergency room visits in intervention to control groups.	6 months
Secondary	Length of stay	Length of stay at 3, 6, and 9 months will be compared in both study groups.	9 months
Secondary	All-cause mortality, morbidity, and MACE.	At 9 months of follow up, compare all-cause mortality, morbidity, and MACE.	9 months
Secondary	Medical intervention	Compare Medical intervention for for acute coronary syndromes or heart failure, including coronary angiography/ angioplasty, injectable therapy or oxygen therapy for both study groups when readmission to hospital.	9 months
Secondary	Emergency Department visits	Any emergency department visits not requiring admission or further intervention will be compared in both study groups at 9 months of follow up.	9 months
Secondary	9 months readmission rates	The readmission rates for 9 months will be compared in both study groups.	9 months
Secondary	Patient-reported quality of life	Patients in both study groups will fill out a quality of life questionnaires	9 months