Telemedicine in High-Risk Cardiovascular Patients Post-ACS
- Conditions
- Cardiovascular DiseasesAcute Coronary Syndrome
- Interventions
- Other: Active ArmOther: Control Arm
- Registration Number
- NCT05015634
- Lead Sponsor
- Imperial College London
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 338
-
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.
- 1 The inability to apply/use the telemonitoring equipmentt
- 2 Life expectancy of 9 months or less.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active Arm 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. Control Arm Control Arm Standard routine clinical care will be carried out, with remote follow up over the phone at 3, 6 and 9 months.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 for acute coronary syndromes or heart failure, including coronary angiography/ angioplasty, injectable therapy or oxygen therapy for both study groups when readmission to hospital.
Emergency Department visits 9 months Any emergency department visits not requiring admission or further intervention will be compared in both study groups at 9 months of follow up.
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
Trial Locations
- Locations (1)
Imperial College Healthcare NHS Trust
🇬🇧London, United Kingdom