IMproving reModeling in Acute myoCardial Infarction Using Live and Asynchronous TElemedicine.
- Conditions
- Medication AdherenceAcute Coronary SyndromeLeft Ventricular Remodeling
- Interventions
- Other: Telemedicine
- Registration Number
- NCT02468349
- Lead Sponsor
- National University Heart Centre, Singapore
- Brief Summary
The proposed research aims to compare Left ventricular remodeling outcomes among patients with AMI and elevated NT-pro-B-type natriuretic peptide receiving telemedicine-guided post-MI treatment vs. non-telemedicine guided treatment.
- Detailed Description
Acute Myocardial Infarction (AMI) accounts for more than 6,000 admissions to Singapore hospitals each year. Contemporary treatment, including percutaneous intervention (angioplasty and stenting) and adjunctive drug therapy, has reduced early mortality from AMI.
In many healthcare systems, Hospital scorecards stipulate prescription of appropriate drugs upon discharge after hospitalization for AMI. These drugs include aspirin, a platelet P2Y12 inhibitor, angiotensin converting enzyme inhibitors (ACE-I) or angiotensin receptor blockers (ARB), beta-blockers and lipid-lowering drugs. Such quality improvement programs have led to an increase in prescription of these drugs upon discharge. Yet, 2 problems remain pervasive:
1. dose optimization; how the investigators escalate patients to the most effective drug doses, and
2. drug adherence; whether patients are taking these drugs regularly.
These 2 problems stem largely from the traditional model of episodic care entailing face-to-face visits between patient and healthcare practitioner. Inadequate dose optimization is most relevant to ACE-I/ARB and beta-blockers as healthcare practitioners necessarily prescribe low doses of these drugs at discharge to avoid excessive lowering of blood pressure soon after an AMI. Yet, these drugs are most effective at preventing adverse ventricular remodeling when patients take them at their maximum tolerated doses. In clinical trials, titrating these ACE-I/ARB and beta-blockers to target doses has required weekly outpatient visits, a model of care that most healthcare systems cannot afford.
The investigators hypothesize that a telemedicine-based system of care will lead to a greater reduction in ventricular remodeling as compared with usual care, by improving dose optimization and adherence to ACE-I/ARB and beta-blockers in patients with recent AMI.
Participants with AMI (n=300) will be recruited during the index hospitalization. A key inclusion criteria is an elevated NT-proBNP measurement during the index hospitalization. Participants will first undergo stratified randomization according to ST-segment classification (STEMI/NSTEMI), thereafter randomized into the Telehealth versus Control group in 1:1 sequential block randomization (blocks of 4 and 6). The telehealth intervention group will have their blood pressure and heart rate monitored twice daily at home for 2 months, with alternating titration between ACE-inhibitors and betablockers weekly during the first 2 months. After 2 months, they will continue on telemedicine consultation for 4 months; coaching on drug adherence, drug side-effects management and monitoring of symptoms. A smartphone-based app developed by PEACH Intellihealth will provide structured health education, medication reminders and real-time text messaging with telehealth professionals.
All participants enrolled will be put on 1 year of dual antiplatelet therapy, have a cardiac MRI done both at baseline and 6-months, and followed up with cardiologist review visit at 1, 6 and 12 months. Major adverse cardiovascular and cerebrovascular events will be assessed during each cardiologist review visit, and beyond 12 months, it will be assessed by either phone calls or online/mailed questionnaires at 18 and 24 months.
Four substudies have been planned: a substudy to assess the impact of telemedicine on readmissions (ALTRA), a substudy to assess the effect of telemedicine on adherence to antiplatelet therapy (TICA), a substudy to assess the cost-effectiveness of telemedicine (CEA) and a substudy to assess the effect of telemedicine on MR-PET measured cardiac work efficiency (CES).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 300
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Telemedicine Telemedicine The telehealth group will be remotely monitored and managed on medication adherence, dosage titration, and management of drug side effects, through a combination of feed-forward blood pressure monitoring, app-based education and medication reminders, and remote consultations.
- Primary Outcome Measures
Name Time Method Difference in Left Ventricular End-Systolic Volume (ml) 6 months Difference in Left Ventricular End-Systolic Volume (ml) measured on cardiac magnetic resonance imaging
- Secondary Outcome Measures
Name Time Method Haemodynamic Stress 6 months Frequency of participants with reduction in NT-proBNP \<20%
Adenosine diphosphate-induced platelet reactivity 6 months Difference in Multiplate ADP test (AU\*min)
Hospitalisation & readmission 2 years Difference in incidence of Death, MI, Stroke, readmission for recurrent ischaemia requiring unplanned revascularization and readmission for heart failure.
Infarct size (grams and % of total LV mass) 6 months Infarct size (grams and % of total LV mass) measured on cardiac magnetic resonance imaging
Trial Locations
- Locations (3)
Tan Tock Seng Hospital
🇸🇬Singapore, Singapore
National University Heart Centre Singapore
🇸🇬Singapore, Singapore
National Heart Centre Singapore
🇸🇬Singapore, National Heart Research Institute, Singapore