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

Acute Coronary Syndrome Clinical Trial

— IMMACULATE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02468349
• Other study ID #: 2014/00793
• Status: Recruiting
• Phase: N/A
• First received: June 7, 2015
• Last updated: March 28, 2018
• Start date: June 2015
• Est. completion date: December 2020

Study information

• Verified date: March 2018
• Source: National University Heart Centre, Singapore
• Contact: Sock Cheng Poh
• Phone: +65 9772 0495
• Email: sock_cheng_poh[@]nuhs.edu.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 85 Years

Eligibility

Inclusion criteria

1. Clinically diagnosed STEMI or NSTEMI* within the last 7 days at high risk of ventricular remodeling

• Typical history of ischemic chest pain or angina equivalent symptoms (e.g. acute onset dyspnea)

• Typical rise or fall of cardiac enzymes with at least one value of cardiac troponin I=10 ug/L.

• ECG changes required for diagnosis of STEMI: =0.1mV ST segment elevation in two or more contiguous limb leads or precordial leads or presence of Q waves =0.02 sec in two or more contiguous limb leads or precordial leads, or new onset left bundle branch block (LBBB), *The definition of STEMI and NSTEMI follows the 3rd universal definition of MI [19]

2. Pre-discharge NTproBNP =300 pg/mL for both STEMI and NSTEMI

3. Undergone PCI for the index event

4. Age >21 years and <85 years

Exclusion criteria

1. Hypersensitivity to ticagrelor, aspirin or any excipients

2. Active pathological bleeding

3. History of intracranial haemorrhage

4. Bacterial Infection within 6 weeks preceding the primary angioplasty, HIV, autoimmune disease (e.g. SLE, rheumatoid arthritis, scleroderma and Grave's disease, etc) or on immunosuppressive therapy

5. Women of child-bearing potential, known to be pregnant, breast-feeding, or intend to become pregnant during the study period

6. Malignancy within last 2 years

7. History of significant valvular heart disease (moderate or severe MS, MR, AS, AR, TR)

8. Planned CABG within the next 6 weeks

9. Unable to be weaned off inotropes or IABP

10. Active asthma or any other contraindications to beta-blockers

11. Arrhythmias precluding proper CMR image acquisition, such as atrial fibrillation and frequent atrial or ventricular ectopy of > 1 in 5 intrinsic QRS complexes

12. Contraindications to cardiac magnetic resonance imaging including claustrophobia, pacemaker or ICD implantation, mechanical valve or other metallic implants

13. Severe liver impairment due to chronic liver disease e.g. advanced alcoholic liver cirrhosis or primary biliary cirrhosis

14. Significant renal impairment (eGFR <50ml min-1), end stage renal failure on renal replacement therapy

15. Anaemia (Hb<10 g/dL).

16. Psychosocial barriers to telemedicine adoption (screening for education level, dementia, substance abuse and other psychological disorders)

17. Participants who cannot be followed up

18. Participants not able or willing to consent for study.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Infarction
• Left Ventricular Remodeling
• Medication Adherence
• Myocardial Infarction
• Ventricular Remodeling

Intervention

Other:
• Telemedicine
Participants enrolled will be randomised 1:1 to either telemedicine arm or standard care arm.

Locations

Country	Name	City	State
Singapore	National Heart Centre Singapore	Singapore	National Heart Research Institute
Singapore	National University Heart Centre Singapore	Singapore
Singapore	Tan Tock Seng Hospital	Singapore

Sponsors (4)

Lead Sponsor	Collaborator
National University Heart Centre, Singapore	National University Hospital, Singapore, National University, Singapore, Tan Tock Seng Hospital

Country where clinical trial is conducted

Singapore, 

References & Publications (1)

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. Erratum in: J Am Coll Cardiol. 2014 Mar 11;63(9):944. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of Life	Difference in QoL outcome measures	2 years
Other	Medication Adherence	Difference in medication adherence score and pill count	12 months
Primary	Difference in Left Ventricular End-Systolic Volume (ml)	Difference in Left Ventricular End-Systolic Volume (ml) measured on cardiac magnetic resonance imaging	6 months
Secondary	Haemodynamic Stress	Frequency of participants with reduction in NT-proBNP <20%	6 months
Secondary	Infarct size (grams and % of total LV mass)	Infarct size (grams and % of total LV mass) measured on cardiac magnetic resonance imaging	6 months
Secondary	Adenosine diphosphate-induced platelet reactivity	Difference in Multiplate ADP test (AU*min)	6 months
Secondary	Hospitalisation & readmission	Difference in incidence of Death, MI, Stroke, readmission for recurrent ischaemia requiring unplanned revascularization and readmission for heart failure.	2 years

External Links

•   Singapore telemedicine guidelines