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

NCT ID: NCT06887257

Last Updated: 2025-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2024-12-15

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

Detailed Description

A prospective, single-centre, randomized study with patients diagnosed with INOCA to assess their participation in a 3-month telehealth-based holistic cardiac rehabilitation program (CRP). Exclusion criteria were based on contraindications for participating in the telehealth CRP: 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. Additionally, patients without a mobile device/tablet/computer with internet access to connect to exercise and educational sessions were excluded. Finally, participants should be stable in terms of angina episodes, defined as the absence of hospitalizations or decompensations in the number of angina episodes, as well as no changes in antianginal medications for 3 months prior to inclusion.

The primary endpoint is the improvement in functional capacity, objectively measured by the change in peak oxygen consumption (VO2peak) obtained from cardiopulmonary exercise testing (CPET) after 3 months of CRP (treatment group), compared to standard recommendations (control group). Secondary endpoints are CRP impact on quality of life, adherence to Mediterranean diet, emotional state, functional independence, angina episodes and sleep quality. The investigators selected pure VSA and pure MCA endotypes for the inclusion, to avoid confusion factors and to see if there were different results between both endotypes. A sample of 24 patients was selected to detect a 4.5 ml/kg/min difference in VO2peak.

The study scheme is as follows:

1. Recruitment: INOCA patients (confirmed diagnosis with microcirculation and provocation testing) are referred from ischemic heart disease consultations.

2. Initial Assessment Visit:

• Part 1: Cardiologist and hemodynamic nurse explain the project, and if the patient agrees to participate, randomization (CRP yes or no) occur, and informed consent is signed. Blood samples are taken for initial assessment (basic profile, haemostasis, lipid profile, and HbA1c). Additionally, scales for quality of life (EuroQol), anxiety and depression (HADS), Mediterranean diet (PREDIMED), weekly exercise volume (IPAQ), functional (Barthel), and angina (SAQ-7) assessments are completed.
• Part 2: Assessment in the cardiac rehabilitation clinic and initial CPET (cardiopulmonary stress test) testing for all patients. If the patient belongs to the CRP group, an individualized exercise prescription is made for the physiotherapist. If not, general exercise recommendations are provided. In both cases, a final CPET visit is scheduled at 3 months.

3. Cardiac Rehabilitation Program (3-month duration, for the intervention group): 2 individualized exercise sessions per week (via Teams platform) with the physiotherapist, 1 educational session per week via Teams with nursing, and 1 educational session per week via Teams with psychology.

4. Final Visit in Cardiac Rehabilitation: Scales wee reassessed, CPET is conducted, and a final medical assessment is performed. A final blood test and nursing assessment is also conducted, including an ad hoc patient experience survey regarding the program. A final medical report with their evolution and recommendations for follow up is given to all patients.

Conditions

INOCA (Ischemia With Non Obstructive Coronary Artery Disease)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cardiac rehabilitation group (treatment group)

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Standard recommendations (control group)

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

Group Type: ACTIVE_COMPARATOR

Standard recommendations

Intervention Type: OTHER

Standard recommendations about exercise, educational and psychologicla advice

Interventions

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

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.

Intervention Type: OTHER

Standard recommendations

Standard recommendations about exercise, educational and psychologicla advice

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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
• Participants should be stable in terms of angina episodes, defined as the absence of hospitalizations or decompensations in the number of angina episodes, as well as no changes in antianginal medications for 3 months prior to inclusion.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spanish Society of Cardiology

OTHER

Sponsor Role: collaborator

Hospital Clinic of Barcelona

OTHER

Sponsor Role: lead

Responsible Party

Margarita Calvo

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Margarita Calvo-Lopez, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic of Barcelona

Locations

Villarroel 170

Barcelona, Barcelona, Spain

Countries

Spain

Other Identifiers

HCB/2024/0926

Identifier Type: -

Identifier Source: org_study_id