Acute Coronary Syndrome, Cardiovascular Diseases
Conditions
Keywords
Myocardial infarction, Acute coronary syndrome, Telemedicine, Heart Attack
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.
Interventions
OTHERActive 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.
OTHERControl Arm
Standard routine clinical care will be carried out, with remote follow up over the phone at 3, 6 and 9 months.
Sponsors
Imperial College London
King Khalid University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
A total of 338 patients will be randomised 1:1 to the 2 trial arms over 9 months.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Hospital Readmission at 6 Months | 6 months | At 6 months of follow up, compare formal admissions and not emergency room visits in intervention to control groups. |
| Emergency Department Visits at 6 Months | 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
| Measure | Time frame | Description |
|---|---|---|
| Length of Stay | From discharge to 9 months follow-up | Length of stay at 3, 6, and 9 months will be compared in both study groups. |
| All-cause Mortality | 6 months | At 6 months of follow up, compare all-cause mortality, morbidity |
| Number of Participants With Major Adverse Cardiac Events (MACE) at 9 Months | 9 months | Number of participants with major adverse cardiac events (MACE) at 9 months follow-up. |
| Medical Intervention | 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. |
| 9 Months Readmission Rates | 9 months | The readmission rates for 9 months will be compared in both study groups. |
| Patient-Reported Quality of Life - 3 Months | 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. |
| Patient-Reported Quality of Life - 6 Months | 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. |
| Patient-Reported Quality of Life - 9 Months | 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. |
Countries
United Kingdom
Contacts
PRINCIPAL_INVESTIGATORRamzi Y Khamis, MB ChB PhD FRCP
Imperial College London
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized Age (years) | 57.6 years STANDARD_DEVIATION 8.7 |
| Current or ex-smoker | 96 Participants |
| Diabetes | 49 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 120 Participants |
| Race (NIH/OMB) Black or African American | 20 Participants |
| Race (NIH/OMB) More than one race | 13 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 156 Participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 290 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 163 | 2 / 167 |
| other Total, other adverse events | 0 / 163 | 0 / 167 |
| serious Total, serious adverse events | 11 / 163 | 37 / 167 |
Outcome results
None listed