Type 2 Myocardial Infarction
Conditions
Keywords
Type 2 myocardial infarction, Secondary myocardial infarction, Cardiac Rehabilitation
Brief summary
The goal of this clinical trial is to determine if a behavioral intervention can increase attendance at cardiac rehabilitation (CR) after secondary/type 2 myocardial infarction in adult patients. The main question it aims to answer is: * Does the ATTEND-CR intervention increase attendance at ≥1 CR exercise session within 140 days of randomization? * Does the intervention increase completion of ≥12 CR exercise sessions within 140 days of randomization? Researchers will compare participants receiving the ATTEND-CR intervention (clinician notifications and a motivational interviewing participant phone call) to usual care to see if attendance and completion of CR improve. Participants: * Clinicians will receive informational messaging regarding CR and the referral process * Participate in a motivational interviewing phone call (intervention group only) * Have follow-up assessments via telephone and electronic health record (EHR) review to track CR attendance, clinical events, and health outcomes
Detailed description
The ATTEND-CR trial ("Activating Teams and Patients to Enhance Attendance at Cardiac Rehabilitation After Secondary Myocardial Infarction") is a single-center pilot randomized clinical trial designed to evaluate strategies to increase participation in cardiac rehabilitation (CR) among patients hospitalized with secondary/type 2 (demand/supply mismatch) myocardial infarction (MI). Although CR has been demonstrated to improve functional capacity, quality of life, and cardiovascular outcomes after acute MI, participation rates remain low, particularly in patients with secondary/type 2 MI. This study tests whether a low-risk, behavioral intervention can improve attendance in CR programs. Participants are randomized to either the ATTEND-CR intervention or usual care. The intervention consists of informational messaging to clinicians regarding CR and the referral process, combined with a follow-up phone call to the patient applying principles of motivational interviewing to support their attendance at CR. Usual care participants receive standard post-MI management without study-driven notifications or motivational support. Participants are followed for 140 days post-randomization. Study procedures include remote follow-up calls and review of electronic health records to capture participation in CR, clinical events, medication use, and patient-reported health status. The study team monitors safety throughout the trial, focusing on adverse events occurring during or shortly after CR sessions and any serious adverse events that arise during the follow-up period.
Interventions
BEHAVIORALClinician-level intervention
The inpatient clinical team receives an EPIC in-basket and email detailing the patient's study participation, benefits of cardiac rehabilitation, and guidance on how to place a cardiac referral if appropriate. If a cardiac rehabilitation referral is not placed within 3 days post-discharge, a follow-up message is sent to one of the patient's outpatient clinician within 4-28 days post-discharge and within 140 days of randomization.
BEHAVIORALPatient-level intervention
Participants receive a phone call applying motivational interviewing principles if a cardiac rehabilitation referral has been placed by their clinical team within 56 days post-discharge and within 140 days of randomization. The phone call aims to discuss cardiac rehabilitation, barriers to participation, and support engagement in cardiac rehabilitation.
Sponsors
Massachusetts General Hospital
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Inpatient at MGH with an index secondary (type 2) MI * Primary care provider (PCP) within the Mass General Brigham (MGB) network with at least one visit in the past 2 years * Anticipated ability to ambulate independently without walking aids or supplemental ambulatory oxygen at discharge * Ability to provide informed consent
Exclusion criteria
* Known severe untreated valvular heart disease or severe prosthetic valve dysfunction * Known hypertrophic obstructive cardiomyopathy * End-stage heart failure (VAD, transplant patient, or undergoing evaluation for VAD or transplant) * Hemodynamic instability at the time of pre-screening * Terminal illness with life expectancy \< 1 year * Severe anemia (hemoglobin \< 8 g/dL) at the time of pre-screening * Active, unstable cancer (excluding non-metastatic skin cancer) or currently receiving intensive cancer therapy * Advanced kidney disease requiring renal replacement therapy * Receiving palliative or comfort care only * Recurrent falls (≥2) or falls with injury in the past year * Physical or cognitive impairment likely to prevent safe participation in exercise over the next 5 months (e.g., significant stroke deficits, dementia) * High-risk for non-adherence to study requirements * Incarcerated individuals * Currently pregnant or within 3 months postpartum * Previously referred to or participated in CR within the past year * Alternative MI subtype (spontaneous \[type 1 MI\] or procedural MI \[type 4 or 5 MI\]) in the past 6 months * Suspected or confirmed coronary mechanism of index MI (vasospasm, embolism, or spontaneous coronary artery dissection) * Anticipated discharge or discharged before enrollment measures can be completed * Anticipated discharge to a facility where independent participation in CR is not feasible * Previously enrolled in or declined participation in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Attended one or more Cardiac Rehabilitation Exercise Session | Within 140 days (inclusive) post-randomization | Attendance at one or more cardiac rehabilitation exercise session |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Cardiac Rehabilitation Referral | Within 140 days (inclusive) post-randomization | Referral to a cardiac rehabilitation program |
| Number of Participants who Completed Cardiac Rehabilitation | Within 140 days (inclusive) post-randomization | Completion defined as attendance at ≥12 cardiac rehabilitation exercise sessions |
| Feasibility indicators | Recruitment Time Frame: Through completion of enrollment, an average of 18 months. Retention Time Frame: Through completion of participant follow-up, an average of 20 weeks. | 1. Recruitment: Proportion of eligible patients randomized; threshold ≥40%. 2. Retention: Proportion completing interim or final follow-up; threshold ≥70%. |
Countries
United States
Contacts
CONTACTCian McCarthy, MB, BCh, BAO, SM
CONTACTConnor Suscha, BS
PRINCIPAL_INVESTIGATORCian P McCarthy, MB, BCh, BAO, SM
Massachusetts General Hospital
Outcome results
None listed