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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02468349 |
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Date of registration:
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07/06/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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IMproving reModeling in Acute myoCardial Infarction Using Live and Asynchronous TElemedicine.
IMMACULATE |
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Scientific title:
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IMproving reModeling in Acute myoCardial Infarction Using Live and Asynchronous TElemedicine. |
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Date of first enrolment:
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June 2015 |
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Target sample size:
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300 |
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Recruitment status: |
Unknown status |
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URL:
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https://clinicaltrials.gov/show/NCT02468349 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Health Services Research. Masking: Single (Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Singapore
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Contacts
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Name:
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Mark Chan |
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Address:
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Telephone:
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Email:
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Affiliation:
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National University Heart Centre, Singapore |
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Name:
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A. Mark Richards |
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Address:
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Telephone:
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Email:
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Affiliation:
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National University Heart Centre, Singapore |
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Name:
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Sock Cheng Poh |
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Address:
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Telephone:
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+65 9772 0495 |
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Email:
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sock_cheng_poh@nuhs.edu.sg |
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Affiliation:
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Key inclusion & exclusion criteria
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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.
Age minimum:
21 Years
Age maximum:
85 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Left Ventricular Remodeling
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Acute Coronary Syndrome
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Medication Adherence
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Intervention(s)
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Other: Telemedicine
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Primary Outcome(s)
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Difference in Left Ventricular End-Systolic Volume (ml)
[Time Frame: 6 months]
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Secondary Outcome(s)
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Adenosine diphosphate-induced platelet reactivity
[Time Frame: 6 months]
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Haemodynamic Stress
[Time Frame: 6 months]
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Hospitalisation & readmission
[Time Frame: 2 years]
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Infarct size (grams and % of total LV mass)
[Time Frame: 6 months]
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Secondary ID(s)
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2014/00793
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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