Telemedicine in High-Risk Cardiovascular Patients Post-ACS

NCT ID: NCT05015634

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 337 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-06
• Study Completion Date: 2025-05-31

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.

Detailed 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.

Conditions

Cardiovascular Diseases; Acute Coronary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Active Arm

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.

Group Type: ACTIVE_COMPARATOR

Active Arm

Intervention Type: 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

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

Group Type: PLACEBO_COMPARATOR

Control Arm

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Control Arm

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King Khalid University

OTHER

Sponsor Role: collaborator

Imperial College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ramzi Y Khamis, MB ChB PhD FRCP

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

Imperial College Healthcare NHS Trust

London, , United Kingdom

Countries

United Kingdom

References

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Other Identifiers

21HH7034

Identifier Type: -

Identifier Source: org_study_id