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| Name | Class |
|---|---|
| National University of Singapore | OTHER |
| National University Hospital, Singapore | OTHER |
| Tan Tock Seng Hospital | OTHER |
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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telemedicine | Experimental | 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. |
|
| Standard care | No Intervention | The standard care group will receive face-to-face consultations at one month, 6 months and 12 months. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telemedicine | Other | Participants enrolled will be randomised 1:1 to either telemedicine arm or standard care arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Left Ventricular End-Systolic Volume (ml) | Difference in Left Ventricular End-Systolic Volume (ml) measured on cardiac magnetic resonance imaging | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Haemodynamic Stress | Frequency of participants with reduction in NT-proBNP <20% | 6 months |
| Infarct size (grams and % of total LV mass) | Infarct size (grams and % of total LV mass) measured on cardiac magnetic resonance imaging |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life | Difference in QoL outcome measures | 2 years |
| Medication Adherence | Difference in medication adherence score and pill count | 12 months |
Inclusion criteria
Clinically diagnosed STEMI or NSTEMI* within the last 7 days at high risk of ventricular remodeling
Pre-discharge NTproBNP ≥300 pg/mL for both STEMI and NSTEMI
Undergone PCI for the index event
Age >21 years and <85 years
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sock Cheng Poh | Contact | +65 9772 0495 | sock_cheng_poh@nuhs.edu.sg | |
| Karen Koh | Contact | +65 67728664 | karen_wl_koh@nuhs.edu.sg |
| Name | Affiliation | Role |
|---|---|---|
| Mark Chan | National University Heart Centre, Singapore | Principal Investigator |
| A. Mark Richards | National University Heart Centre, Singapore | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Heart Centre Singapore | Recruiting | Singapore | National Heart Research Institute | 169609 | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23973701 | Background | Arnold SV, Spertus JA, Masoudi FA, Daugherty SL, Maddox TM, Li Y, Dodson JA, Chan PS. Beyond medication prescription as performance measures: optimal secondary prevention medication dosing after acute myocardial infarction. J Am Coll Cardiol. 2013 Nov 5;62(19):1791-801. doi: 10.1016/j.jacc.2013.04.102. Epub 2013 Aug 21. | |
| 33377898 |
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| ID | Term |
|---|---|
| D020257 | Ventricular Remodeling |
| D055118 | Medication Adherence |
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
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| ID | Term |
|---|---|
| D017216 | Telemedicine |
| ID | Term |
|---|---|
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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| 6 months |
| Adenosine diphosphate-induced platelet reactivity | Difference in Multiplate ADP test (AU*min) | 6 months |
| Hospitalisation & readmission | Difference in incidence of Death, MI, Stroke, readmission for recurrent ischaemia requiring unplanned revascularization and readmission for heart failure. | 2 years |
| National University Heart Centre Singapore | Recruiting | Singapore | 119228 | Singapore |
|
| Tan Tock Seng Hospital | Recruiting | Singapore | 308433 | Singapore |
|
| Chan MY, Koh KWL, Poh SC, Marchesseau S, Singh D, Han Y, Ng F, Lim E, Prabath JF, Lee CH, Sim HW, Chen R, Carvalho L, Tan SH, Loh JPY, Tan JWC, Kuwelker K, Amanullah RM, Chin CT, Yip JWL, Lee CY, Gan J, Lo CY, Ho HH, Hausenloy DJ, Tai BC, Richards AM; IMMACULATE Investigators. Remote Postdischarge Treatment of Patients With Acute Myocardial Infarction by Allied Health Care Practitioners vs Standard Care: The IMMACULATE Randomized Clinical Trial. JAMA Cardiol. 2021 Jul 1;6(7):830-835. doi: 10.1001/jamacardio.2020.6721. |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |