Effect of an assisted self-management program to prevent new life-threatening events post heart attack

Not Applicable

Recruiting

• Conditions: Type 1 myocardial infarction; Cardiovascular - Coronary heart disease

• Registration Number: ACTRN12622000316707
• Lead Sponsor: The University of Western Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-02-21
• Last Update Posted: 12 December 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 650

Inclusion Criteria

Persons aged at least 18 years;
Inpatient diagnosis of suspected ST-segment elevation MI (STEMI), or high-risk and intermediate-risk non-STEMI (NSTEMI) acute coronary syndrome by ACS Guidelines and 4th universal definition of MI. Specifically, Troponin Pattern 1 (Acute Myocardial Injury): A rise and/or fall in troponin from at least 2 samples defined as: (1) Hs-Troponin T: A rise and/or fall in the absolute troponin level of >2.5ng/L/hour (ie a change of >15ng/L in 6 hours) between any troponin results before randomisation OR a relative change in troponin >20% between earlier and later samples (ie 100*(hs-TnT[later] - hs-TnT[earlier] / hs-TnT[earlier]) >20%) documented on any troponin results before randomisation. (2) Hs-Troponin I: An absolute elevation of >10 times the upper limit of normal specific for that assay, using gender-specific cut-points if implemented locally OR change in troponin >20% between earlier and later samples (ie 100*(hs-TnI[later] - hs-TnI[earlier] / hs-TnI[earlier]) >20% documented on any troponin results before randomisation;
Regarded by the treating cardiologist to be suitable for cardiac rehabilitation.

Exclusion Criteria

Prior cardiac rehabilitation;
Clinical diagnosis of uncompensated severe heart failure (Class IV);
Uncontrolled arrhythmia or angina;
Severe or symptomatic aortic stenosis;
Co-existing clinical diagnosis of non-cardiac condition that would prevent participation (eg advanced dementia, severe rheumatoid arthritis, severe frailty, terminal illness).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients completing at least 80% of all scheduled sessions (yes/no) for standard outpatient rehabilitation versus SPAN. This will be extracted from either hard copy or electronic medical records documented as part of normal clinical responsibilities and from direct access to the personalised rehabilitation plan template and follow-up case report form (CRF) kept by the secondary prevention coordinator, and assessed using a logistic regression analysis with stratification by site. [ Median of 3 months follow-up at the time of intervention completion. ]

Secondary Outcome Measures

Name	Time	Method
evel of health service utilisation as assessed by data linkage to health service records.[ Median of 12 months follow-up assessed from the time of intervention commencement to 12 months post-intervention commencement.];Adherence to guideline indicated medications as assessed by data linkage to medical records.[ Median of 12 months follow-up assessed from the time of intervention commencement to 12 months post-intervention commencement.];All-cause death as assessed by data linkage to the National Health Index. [ Median of 12 months follow-up assessed from the time of intervention commencement to 12 months post-intervention commencement.]