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

Primary Purpose

Left Ventricular Remodeling, Medication Adherence, Acute Coronary Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Telemedicine
Sponsored by
National University Heart Centre, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Left Ventricular Remodeling focused on measuring Acute Myocardial Infarction, Telemedicine, Readmissions

Eligibility Criteria

21 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Heart Centre SingaporeRecruiting
  • National University Heart Centre SingaporeRecruiting
  • Tan Tock Seng HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Telemedicine

Standard care

Arm Description

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.

The standard care group will receive face-to-face consultations at one month, 6 months and 12 months.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Haemodynamic Stress
Frequency of participants with reduction in NT-proBNP <20%
Infarct size (grams and % of total LV mass)
Infarct size (grams and % of total LV mass) measured on cardiac magnetic resonance imaging
Adenosine diphosphate-induced platelet reactivity
Difference in Multiplate ADP test (AU*min)
Hospitalisation & readmission
Difference in incidence of Death, MI, Stroke, readmission for recurrent ischaemia requiring unplanned revascularization and readmission for heart failure.

Full Information

First Posted
June 7, 2015
Last Updated
March 28, 2018
Sponsor
National University Heart Centre, Singapore
Collaborators
National University of Singapore, National University Hospital, Singapore, Tan Tock Seng Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02468349
Brief Title
IMproving reModeling in Acute myoCardial Infarction Using Live and Asynchronous TElemedicine.
Acronym
IMMACULATE
Official Title
IMproving reModeling in Acute myoCardial Infarction Using Live and Asynchronous TElemedicine.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University Heart Centre, Singapore
Collaborators
National University of Singapore, National University Hospital, Singapore, Tan Tock Seng Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: dose optimization; how the investigators escalate patients to the most effective drug doses, and 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Left Ventricular Remodeling, Medication Adherence, Acute Coronary Syndrome
Keywords
Acute Myocardial Infarction, Telemedicine, Readmissions

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Telemedicine
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
The standard care group will receive face-to-face consultations at one month, 6 months and 12 months.
Intervention Type
Other
Intervention Name(s)
Telemedicine
Intervention Description
Participants enrolled will be randomised 1:1 to either telemedicine arm or standard care arm.
Primary Outcome Measure Information:
Title
Difference in Left Ventricular End-Systolic Volume (ml)
Description
Difference in Left Ventricular End-Systolic Volume (ml) measured on cardiac magnetic resonance imaging
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Haemodynamic Stress
Description
Frequency of participants with reduction in NT-proBNP <20%
Time Frame
6 months
Title
Infarct size (grams and % of total LV mass)
Description
Infarct size (grams and % of total LV mass) measured on cardiac magnetic resonance imaging
Time Frame
6 months
Title
Adenosine diphosphate-induced platelet reactivity
Description
Difference in Multiplate ADP test (AU*min)
Time Frame
6 months
Title
Hospitalisation & readmission
Description
Difference in incidence of Death, MI, Stroke, readmission for recurrent ischaemia requiring unplanned revascularization and readmission for heart failure.
Time Frame
2 years
Other Pre-specified Outcome Measures:
Title
Quality of Life
Description
Difference in QoL outcome measures
Time Frame
2 years
Title
Medication Adherence
Description
Difference in medication adherence score and pill count
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria 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] 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 Hypersensitivity to ticagrelor, aspirin or any excipients Active pathological bleeding History of intracranial haemorrhage 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 Women of child-bearing potential, known to be pregnant, breast-feeding, or intend to become pregnant during the study period Malignancy within last 2 years History of significant valvular heart disease (moderate or severe MS, MR, AS, AR, TR) Planned CABG within the next 6 weeks Unable to be weaned off inotropes or IABP Active asthma or any other contraindications to beta-blockers Arrhythmias precluding proper CMR image acquisition, such as atrial fibrillation and frequent atrial or ventricular ectopy of > 1 in 5 intrinsic QRS complexes Contraindications to cardiac magnetic resonance imaging including claustrophobia, pacemaker or ICD implantation, mechanical valve or other metallic implants Severe liver impairment due to chronic liver disease e.g. advanced alcoholic liver cirrhosis or primary biliary cirrhosis Significant renal impairment (eGFR <50ml min-1), end stage renal failure on renal replacement therapy Anaemia (Hb<10 g/dL). Psychosocial barriers to telemedicine adoption (screening for education level, dementia, substance abuse and other psychological disorders) Participants who cannot be followed up Participants not able or willing to consent for study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sock Cheng Poh
Phone
+65 9772 0495
Email
sock_cheng_poh@nuhs.edu.sg
First Name & Middle Initial & Last Name or Official Title & Degree
Karen Koh
Phone
+65 67728664
Email
karen_wl_koh@nuhs.edu.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Chan
Organizational Affiliation
National University Heart Centre, Singapore
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
A. Mark Richards
Organizational Affiliation
National University Heart Centre, Singapore
Official's Role
Study Chair
Facility Information:
Facility Name
National Heart Centre Singapore
City
Singapore
State/Province
National Heart Research Institute
ZIP/Postal Code
169609
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Derek Hausenloy
Phone
+65 65166719
Email
d.hausenloy@ucl.ac.uk
First Name & Middle Initial & Last Name & Degree
Derek Hausenloy
Facility Name
National University Heart Centre Singapore
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sock Cheng Poh
Phone
+65 66015951
Email
sock_cheng_poh@nuhs.edu.sg
First Name & Middle Initial & Last Name & Degree
Karen Koh
Phone
+65 67726884
First Name & Middle Initial & Last Name & Degree
Mark Chan
Facility Name
Tan Tock Seng Hospital
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tasha Mahadi
Phone
+65 63578124
Email
tashama@ttsh.com.sg
First Name & Middle Initial & Last Name & Degree
Hee Hwa Ho
First Name & Middle Initial & Last Name & Degree
Yeong Shyan Lee
First Name & Middle Initial & Last Name & Degree
Prabath F Joseph

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23973701
Citation
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.
Results Reference
background
PubMed Identifier
33377898
Citation
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.
Results Reference
derived

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

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