NCT07485491

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

Trial Health

63
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Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
22mo left

Started Jun 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 20, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

1.8 years

First QC Date

March 12, 2026

Last Update Submit

March 16, 2026

Conditions

Keywords

Type 2 myocardial infarctionSecondary myocardial infarctionCardiac Rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Who Attended one or more Cardiac Rehabilitation Exercise Session

    Attendance at one or more cardiac rehabilitation exercise session

    Within 140 days (inclusive) post-randomization

Secondary Outcomes (3)

  • Number of Participants With a Cardiac Rehabilitation Referral

    Within 140 days (inclusive) post-randomization

  • Number of Participants who Completed Cardiac Rehabilitation

    Within 140 days (inclusive) post-randomization

  • 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.

Other Outcomes (14)

  • All-cause mortality

    Within 140 days (inclusive) post-randomization

  • All-cause hospitalization

    Within 140 days (inclusive) post randomization

  • Major adverse cardiovascular event

    Within 140 days (inclusive) post randomization

  • +11 more other outcomes

Study Arms (2)

Intervention Arm (ATTEND-CR):

EXPERIMENTAL

Participants clinicians receive an informational message about cardiac rehabilitation and the cardiac rehabilitation referral process. Participants who are referred to cardiac rehabilitation receive a phone call post-discharge applying principles of motivational interviewing. The goal is to encourage cardiac rehabilitation attendance.

Behavioral: Clinician-level interventionBehavioral: Patient-level intervention

Usual Care Arm

NO INTERVENTION

Participants receive standard post-MI care without clinician informative messaging or a motivational interviewing phone call from the study team. They may still be referred to and attend CR based on usual clinical practice.

Interventions

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.

Intervention Arm (ATTEND-CR):

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.

Intervention Arm (ATTEND-CR):

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Study Officials

  • Cian P McCarthy, MB, BCh, BAO, SM

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cian McCarthy, MB, BCh, BAO, SM

CONTACT

Connor Suscha, BS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 12, 2026

First Posted

March 20, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2028

Last Updated

March 20, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

De-identified data generated from this study will be submitted to a data repository in accordance with NIH data sharing guidelines.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Anticipated to be available at the time of publication of the study results.

Locations