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Completed

NCT Number: NCT05015634

Telemedicine in High-Risk Cardiovascular Patients Post-ACS

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.

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Key information

Conditions

Cardiovascular Diseases Acute Coronary Syndrome Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Imperial College Healthcare NHS Trust

London, W12 0NN, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Control Arm

Other

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

Primary outcomes

  1. Number of Participants With Hospital Readmission at 6 Months

    Time frame: 6 months

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

  2. Emergency Department Visits at 6 Months

    Time frame: 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.

Secondary outcomes

  1. Length of Stay

    Time frame: From discharge to 9 months follow-up

    Length of stay at 3, 6, and 9 months will be compared in both study groups.

  2. All-cause Mortality

    Time frame: 6 months

    At 6 months of follow up, compare all-cause mortality, morbidity

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

    Time frame: 9 months

    Number of participants with major adverse cardiac events (MACE) at 9 months follow-up.

  4. Medical Intervention

    Time frame: 6 months

    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.

  5. 9 Months Readmission Rates

    Time frame: 9 months

    The readmission rates for 9 months will be compared in both study groups.

  6. Patient-Reported Quality of Life - 3 Months

    Time frame: 3 months

    Quality of life was assessed using the SF-36 and Seattle Angina Questionnaire-7 (SAQ-7). Both instruments generate domain scores from 0-100, with higher scores indicating better health status or angina-related quality of life. Questionnaires were completed at baseline (pre-discharge) and 3 months post-discharge, and follow-up scores were compared with baseline values.

  7. Patient-Reported Quality of Life - 6 Months

    Time frame: 6 months

    Quality of life was assessed using the SF-36 and Seattle Angina Questionnaire-7 (SAQ-7). Both instruments generate domain scores from 0-100, with higher scores indicating better health status or angina-related quality of life. Questionnaires were completed at baseline (pre-discharge) and 6 months post-discharge, and follow-up scores were compared with baseline values.

  8. Patient-Reported Quality of Life - 9 Months

    Time frame: 9 months

    Quality of life was assessed using the SF-36 and Seattle Angina Questionnaire-7 (SAQ-7). Both instruments generate domain scores from 0-100, with higher scores indicating better health status or angina-related quality of life. Questionnaires were completed at baseline (pre-discharge) and 9 months post-discharge, and follow-up scores were compared with baseline values.

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • King Khalid University

Registry information

Official study title

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

Acronym: TELE-ACS

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 20, 2021
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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