Telemedicine in High-Risk Cardiovascular Patients Post-ACS

NCT05015634 | Completed Results

• 1 other identifier: 21HH7034
• Study Type: interventional
• Target: 337
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiovascular Diseases; Acute Coronary Syndrome

Keywords

Myocardial infarction; Acute coronary syndrome; Telemedicine; Heart Attack

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Hospital Readmission at 6 Months

  At 6 months of follow up, compare formal admissions and not emergency room visits in intervention to control groups.

  6 months

• Emergency Department Visits at 6 Months

  Any emergency department visits not requiring admission or further intervention will be compared in both study groups at 6 months of follow up.

  6 Months

Secondary Outcomes (8)

• Length of Stay

  From discharge to 9 months follow-up

• All-cause Mortality

  6 months

• Number of Participants With Major Adverse Cardiac Events (MACE) at 9 Months

  9 months

• Medical Intervention

  6 months

• 9 Months Readmission Rates

  9 months

Study Arms (2)

Active Arm

ACTIVE COMPARATOR

Patients will be discharged from the hospital with the telemedicine package. If the patient develops possible cardiac symptoms and seeks medical attention, the data provided by the telemedicine package will be acted upon, as appropriate, by the trial cardiology team. With remote follow up over the phone at 3, 6 and 9 months.

Other: Active Arm

Control Arm

PLACEBO COMPARATOR

Standard routine clinical care will be carried out, with remote follow up over the phone at 3, 6 and 9 months.

Other: Control Arm

Interventions

Active Arm OTHER

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.

Active Arm

Control Arm OTHER

Standard routine clinical care will be carried out, with remote follow up over the phone at 3, 6 and 9 months.

Control Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ACS Patients diagnosed with elevated hs-cTnI I who have undergone coronary intervention for NSTEMI or STEMI or unstable angina.
• 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.
• Access to a smartphone or smart device.

You may not qualify if:

• The inability to apply/use the telemonitoring equipmentt
• Life expectancy of 9 months or less.

Sponsors & Collaborators

• Imperial College London: lead
• King Khalid University: collaborator

Study Sites (1)

Imperial College Healthcare NHS Trust

London, W12 0NN, United Kingdom

Location

Related Publications (9)

• 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.

  PMID: 28728745 BACKGROUND

• 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.

  PMID: 31407368 BACKGROUND

• 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.

  PMID: 25237046 BACKGROUND

• 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.

  PMID: 28153989 BACKGROUND

• 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.

  PMID: 31941686 BACKGROUND

• 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.

  PMID: 25046174 BACKGROUND

• 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.

  PMID: 32283124 BACKGROUND

• 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.

  PMID: 32473113 BACKGROUND

• Alshahrani NS, Hartley A, Howard J, Hajhosseiny R, Khawaja S, Seligman H, Akbari T, Alharbi BA, Bassett P, Al-Lamee R, Francis D, Kaura A, Kelshiker MA, Peters NS, Khamis R. Randomized Trial of Remote Assessment of Patients After an Acute Coronary Syndrome. J Am Coll Cardiol. 2024 Jun 11;83(23):2250-2259. doi: 10.1016/j.jacc.2024.03.398. Epub 2024 Apr 6.

  PMID: 38588928 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Acute Coronary Syndrome; Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Results Point of Contact

• Title: Prof Ramzi Khamis
• Organization: Imperial College London

r.khamis@imperial.ac.uk

0207 594 6842

Study Officials

• Ramzi Y Khamis, MB ChB PhD FRCP

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A total of 338 patients will be randomised 1:1 to the 2 trial arms over 9 months.

Study Record Dates

• First Submitted: August 11, 2021
• First Posted: August 20, 2021
• Study Start: January 6, 2022
• Primary Completion: February 28, 2025
• Study Completion: May 31, 2025
• Last Updated: March 17, 2026
• Results First Posted: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)