NCT02468349

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

June 7, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 10, 2015

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

March 29, 2018

Status Verified

March 1, 2018

Enrollment Period

4.5 years

First QC Date

June 7, 2015

Last Update Submit

March 28, 2018

Conditions

Left Ventricular RemodelingMedication AdherenceAcute Coronary Syndrome

Keywords

Acute Myocardial InfarctionTelemedicineReadmissions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Haemodynamic Stress

    6 months

  • Infarct size (grams and % of total LV mass)

    6 months

  • Adenosine diphosphate-induced platelet reactivity

    6 months

  • Hospitalisation & readmission

    2 years

Other Outcomes (2)

  • Quality of Life

    2 years

  • Medication Adherence

    12 months

Study Arms (2)

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.

Other: Telemedicine

Standard care

NO INTERVENTION

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

Interventions

TelemedicineOTHER

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

Telemedicine

Eligibility Criteria

Age21 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

National Heart Centre Singapore

Singapore, National Heart Research Institute, 169609, Singapore

RECRUITING

National University Heart Centre Singapore

Singapore, 119228, Singapore

RECRUITING

Tan Tock Seng Hospital

Singapore, 308433, Singapore

RECRUITING

Related Publications (2)

  • 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.

    PMID: 23973701BACKGROUND

  • 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.

    PMID: 33377898DERIVED

MeSH Terms

Conditions

Ventricular RemodelingMedication AdherenceAcute Coronary Syndrome

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Mark Chan

    National University Heart Centre, Singapore

    PRINCIPAL INVESTIGATOR

  • A. Mark Richards

    National University Heart Centre, Singapore

    STUDY CHAIR

Central Study Contacts

Sock Cheng Poh

CONTACT

+65 9772 0495sock_cheng_poh@nuhs.edu.sg

Karen Koh

CONTACT

+65 67728664karen_wl_koh@nuhs.edu.sg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
A/Prof Mark Chan

Study Record Dates

First Submitted

June 7, 2015

First Posted

June 10, 2015

Study Start

June 1, 2015

Primary Completion

December 1, 2019

Study Completion

December 1, 2020

Last Updated

March 29, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

SG(3)