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NCT Number: NCT07745894

VWCR to Improve Cardiovascular Health and Outcomes Among Cardiac Patients: A Multicenter Randomized Clinical Trial Protocol (Destination Cardiac Rehab Study)

The purpose of this research is to compare health outcomes and participation between a virtual world cardiac rehabilitation (Destination Cardiac Rehab) program and the standard of care Center-based Cardiac Rehabilitation program. Destination Cardiac Rehab, developed with input from patients with heart disease and their caregivers, is a 3-D, interactive program offering an affordable telehealth option for cardiac rehabilitation (cardiac rehab) that can be done from home or any place that you can access the Internet with a computer.

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Key information

Conditions

Heart Diseases Cardiovascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Irvine, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Indication for CR according to Centers for Medicare & Medicaid Services (CMS) guidelines:
  • Myocardial infarction within the preceding 12 months
  • Coronary artery bypass surgery
  • Current stable angina (chest pain)
  • Heart valve repair or replacement
  • Percutaneous transluminal coronary angioplasty (PTCA) or coronary stenting
  • Heart or heart-lung transplant
  • Stable chronic heart failure
  • Aged ≥18 years
  • Basic Internet navigation skills
  • Active email address

Exclusion criteria

  • High risk patients according to the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) risk stratification103 given safety concern of unsupervised exercise:
  • Sudden cardiac arrest survivor
  • Receiving continuous inotropic support
  • Presence of a mechanical circulatory support device
  • Decompensated heart failure
  • Symptomatic valvular heart disease
  • Uncontrolled angina
  • Presence of hemodynamically unstable dysrhythmias (e.g., ventricular tachycardia)
  • Pregnant (due to associated hormonal and weight changes)
  • Non-English-speaking
  • Visual/hearing impairment or mental disability that would preclude independent use of the VW platform

Treatment and study plan

Virtual Cardiac Rehabilitation

Other
  • Weekly Virtual Cardiac Rehabilitation Session
  • Virtual Nurse Coaching Visit (frequency: weekly)
  • Virtual Exercise Physiologist Visit (frequency: weekly)
  • Self-Directed Exercise: 3 sessions per week

In-Person Cardiac Rehabilitation

Other

Participants will attend three in-person cardiac rehabilitation sessions per week, each including:

  • Supervised exercise under the guidance of an Exercise Physiologist
  • Educational components related to cardiac health and lifestyle

Primary outcomes

  1. Change in LE8 composite score

    Time frame: Baseline, 3 Months, 6 Months

    Life's Essential 8 score is a composite cardiovascular health (CVH) score developed by the American Heart Association (AHA) to quantify and track an individual's heart- and brain-health based on eight key lifestyle behaviors and clinical health factors (healthy diet, physical activity, nicotine exposure, sleep health, body mass index, lipids, glucose and blood pressure). The score ranges from 0 to 100 points, with higher scores indicating better overall cardiovascular health.

    Interpretation of the composite score usually follows these general categories:

    0-49: Low cardiovascular health 50-79: Moderate cardiovascular health 80-100: High (optimal) cardiovascular health

Secondary outcomes

  1. Number of CV-related hospital readmissions

    Time frame: 3 Months, 6 Months

    Number of CV-related hospital readmissions will be defined as the total number of participants readmitted to the hospital for a cardiovascular-related issue.

  2. Number of Deaths

    Time frame: 3 Months, 6 Months

    Number of deaths will be defined as the total number of participants who die, regardless of cause

  3. Number of CV Deaths

    Time frame: 3 Months, 6 Months

    Number of CV deaths will be defined as the total number of participants who die due to cardiovascular (CV)-related causes.

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Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Library of Medicine (NLM)

Registry information

Official study title

Virtual World-based Cardiac Rehabilitation to Improve Cardiovascular Health and Outcomes Among Cardiac Patients: A Multicenter Randomized Clinical Trial Protocol (Destination Cardiac Rehab Study)

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 4, 2026
Registry last updated
Aug 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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