Acute Coronary Syndrome Clinical Trial
Official title:
IMproving reModeling in Acute myoCardial Infarction Using Live and Asynchronous TElemedicine.
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.
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).
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