TELE-ACS: Telemedicine in High-Risk Cardiovascular Patients Post-ACS

Sponsor

Imperial College London (Other)

Overall Status

Recruiting

CT.gov ID

NCT05015634

Collaborator

King Khalid University (Other)

338

Enrollment

Location

Arms

35.8

Anticipated Duration (Months)

9.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases Acute Coronary Syndrome	Other: Active Arm Other: Control Arm	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

338 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Jan 6, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	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.
Placebo Comparator: Control Arm Standard routine clinical care will be carried out, with remote follow up over the phone at 3, 6 and 9 months.	Other: Control Arm Standard routine clinical care will be carried out, with remote follow up over the phone at 3, 6 and 9 months.

Arm

Intervention/Treatment

Active Comparator: 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.

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.

Placebo Comparator: Control Arm

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

Other: Control Arm

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

Outcome Measures

Primary Outcome Measures

All hospital readmission rates [6 months]
At 6 months of follow up, compare formal admissions and not emergency room visits in intervention to control groups.

Secondary Outcome Measures

Length of stay [9 months]
Length of stay at 3, 6, and 9 months will be compared in both study groups.
All-cause mortality, morbidity, and MACE. [9 months]
At 9 months of follow up, compare all-cause mortality, morbidity, and MACE.
Medical intervention [9 months]
Compare Medical intervention for ACS or heart failure.
Emergency Department visits [9 months]
At 9 months of follow up, emergency department visits not requiring admission will be compared in both study groups.
9 months readmission rates [9 months]
The readmission rates for 9 months will be compared in both study groups.
Patient-reported quality of life [9 months]
Patients in both study groups will fill out a quality of life questionnaires

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.