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Clinical Trials/NCT02468349
NCT02468349
Unknown
N/A

IMproving reModeling in Acute myoCardial Infarction Using Live and Asynchronous TElemedicine.

National University Heart Centre, Singapore3 sites in 1 country300 target enrollmentJune 2015

Overview

Phase
N/A
Intervention
Not specified
Conditions
Left Ventricular Remodeling
Sponsor
National University Heart Centre, Singapore
Enrollment
300
Locations
3
Primary Endpoint
Difference in Left Ventricular End-Systolic Volume (ml)
Last Updated
8 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
June 2015
End Date
December 2020
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
National University Heart Centre, Singapore
Responsible Party
Principal Investigator
Principal Investigator

Mark Chan

A/Prof Mark Chan

National University Heart Centre, Singapore

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Difference in Left Ventricular End-Systolic Volume (ml)

Time Frame: 6 months

Difference in Left Ventricular End-Systolic Volume (ml) measured on cardiac magnetic resonance imaging

Secondary Outcomes

  • Adenosine diphosphate-induced platelet reactivity(6 months)
  • Haemodynamic Stress(6 months)
  • Hospitalisation & readmission(2 years)
  • Infarct size (grams and % of total LV mass)(6 months)

Study Sites (3)

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