Impact of a Corrie Cardiac Rehabilitation Program (mTECH-Rehab)

Johns Hopkins University

Status: Enrolling

Conditions: Coronary Artery Occlusion; Coronary Artery Disease; Coronary Artery Stenosis Stent; Myocardial Ischemia; Valve Heart Disease; Bypass Graft Occlusion; Myocardial Infarction

Treatments: Combination Product: Corrie Hybrid Cardiac Rehabilitation Program

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05238103

IRB00308410

Details and patient eligibility

About

In this randomized clinical trial, the researchers are investigating whether a multi-component virtual/hybrid cardiac rehabilitation program will improve functional status, cholesterol level, overall cardiovascular health, individual risk factors, quality of life and mental health for patients who have recently been diagnosed with myocardial infarction, received a coronary stent, underwent heart surgery or catheter-based valve replacement, as compared to usual care.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• 18 years or older
• Individuals admitted to the hospital for the following conditions or interventions during the index admission: Acute myocardial infarction (STEMI or NSTEMI type 1), Coronary artery bypass grafting (CABG), and Coronary artery angioplasty/stenting (PCI), Heart valve surgery, catheter-based aortic valve replacement (TAVR).

Exclusion Criteria

• Non-English speaking

• Symptomatic severe aortic stenosis or other severe valvular disease

• Physical disability that would preclude safe and adequate exercise performance

• Hypertrophic obstructive cardiomyopathy with peak resting left ventricular outflow gradient of >25 mmHg

• Known aortic dissection

• Severe resting arterial hypertension (Systolic blood pressure >200 mmHg or diastolic BP >110mmHg) at baseline assessment

• Mental impairment leading to inability to cooperate with study procedures

• Untreated high degree atrioventricular block

• Atrial fibrillation with uncontrolled ventricular rate (Heart rate >110 at rest) at baseline assessment

• History of cardiac arrest or sudden death

• Myocardial infarction or cardiac surgery complications with cardiogenic shock and/or congestive heart failure and/or signs/symptoms of post-procedure ischemia

• Left ventricular ejection fraction <40%

• History of Clinically significant depression

• Visual or hearing impairment which precludes the use of the intervention

• Presence of cardiac defibrillator

• Incomplete revascularization procedure

• History of one or more episodes of falls in the last year

• Pregnancy

  • If patients are deemed clinically unstable and unable to participate at the time of initial screening, the research team member may return at a later date to determine whether this status has changed.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 2 patient groups

Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group)

Experimental group

Description:

Receives Corrie Virtual Cardiac Rehabilitation Program along with option to continue traditional, center-based cardiac rehabilitation.

Treatment:

Combination Product: Corrie Hybrid Cardiac Rehabilitation Program

Facilitated Center-Based Cardiac Rehabilitation Program (Control Group)

No Intervention group

Description:

Receives traditional, center-based cardiac rehabilitation. The study team will help facilitate the logistics of receiving center-based cardiac rehabilitation, including proper referrals.