RECOVER WITH INOCA: A Study of a Cardiac Rehabilitation Program in Patients With Ischemia With Nonobstructive Coronary Artery Disease (INOCA)

NCT06887257 | Completed

• 1 other identifier: HCB/2024/0926
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if a cardiac rehabilitation program (CRP) improves functional capacity in adults with INOCA (ischemia with non obstructive coronary arteries). The main questions it aims to answer are:

• Does CRP improves maximal functional capacity (measured by VO2peak) in INOCA patients?
• Does CRP improve as well quality of life, adherence to Mediterranean diet, emotional state, functional independence angina episodes and sleep quality? Researchers will compare CRP (treatment group) to standard recommendations (control group) to see if CRP works better for INOCA patients Participants will: Take part of CRP or standard recommendations for 3 months Visit the clinic in the beginning and in the end of the study for checkups and tests

Conditions

INOCA (Ischemia With Non Obstructive Coronary Artery Disease)

Keywords

INOCA; Cardiac rehabilitation; Functional capacity

Outcome Measures

Primary Outcomes (1)

• Maximal functional capacity

  Change in VO2peak measured with CPET (cardiopulmonary stress test)

  3 months

Secondary Outcomes (6)

• EuroQol (EQ-5D)

  3 months

• PREDIMED

  3 months

• HADS

  3 months

• Barthel Score

  3 months

• Angina episodes

  3 months

Study Arms (2)

Cardiac rehabilitation group (treatment group)

EXPERIMENTAL

3-mont telematic cardiac rehabilitation program for 3 months, including exercise, educational and psychological sessions

Other: Telematic cardiac rehabilitation program, that includes exercise, educational and psychological sessions during 3 months

Standard recommendations (control group)

ACTIVE COMPARATOR

Standard recommendations about exercise, education and psychological advise for INOCA patients

Other: Standard recommendations

Interventions

Telematic cardiac rehabilitation program, that includes exercise, educational and psychological sessions during 3 months OTHER

2 group and telematic exercise sessions/week, 1 educational session/week and 1 psychological session/week, during 3 months. There are no drugs or devices involved in the intervention.

Cardiac rehabilitation group (treatment group)

Standard recommendations OTHER

Standard recommendations about exercise, educational and psychologicla advice

Standard recommendations (control group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All men or women \>18 years old with cath lab diagnosis of INOCA of 2 possible endotypes: vasoespasm or microvascular disease.
• All participants must have a mobile device/tablet/computer with internet access to connect to exercise and educational sessions

You may not qualify if:

• Alarm signs in the stress test (ventricular arrhythmias, hypotensive response, ST segment changes, or symptoms of ischemia)
• Left ventricular ejection fraction (LVEF) \<40%, or presence of pacemakers/defibrillators

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead
• Spanish Society of Cardiology: collaborator

Study Sites (1)

Villarroel 170

Barcelona, Barcelona, 08036, Spain

Location

Study Officials

• Margarita Calvo-Lopez, MD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

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 14, 2025
• First Posted: March 20, 2025
• Study Start: September 1, 2024
• Primary Completion: December 15, 2024
• Study Completion: December 15, 2024
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 1 year after the publication of results
• Access Criteria: Access to IPD and supporting information will be granted to qualified researchers, healthcare professionals, and regulatory authorities for scientific, clinical, or public health purposes. Requests will be reviewed by an independent data access committee to ensure compliance with ethical and legal requirements. Available Data: De-identified IPD, study protocol, statistical analysis plan, informed consent form template, and study results summary. Access Mechanism: Applicants must submit a research proposal, sign a data use agreement (DUA), obtain committee approval, and access data via a secure platform. Ethical and Legal Compliance: Access will follow GDPR, HIPAA, and ethical guidelines, ensuring de-identification and restricted use for approved research purposes. Data Availability: Data will be accessible for at least five years post-publication, with potential extensions. Contact: For access requests, contact margacal1912@gmail.com

Locations

ES (1)