Telemedicine in High-Risk Cardiovascular Patients Post-ACS (TELE-ACS)

Imperial College London

Status: Completed

Conditions: Acute Coronary Syndrome; Cardiovascular Diseases

Treatments: Other: Active Arm; Other: Control Arm

Study type: Interventional

Funder types: Other

Identifiers

NCT05015634

21HH7034

Details and patient eligibility

About

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.

Full 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.

Enrollment: 337 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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337 participants in 2 patient groups, including a placebo group

Active Arm

Active Comparator group

Description:

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.

Treatment:

Other: Active Arm

Control Arm

Placebo Comparator group

Description:

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

Treatment:

Other: Control Arm