INOCA (Ischemia With Non Obstructive Coronary Artery Disease)NCT06887257
RECOVER WITH INOCA: A Study of a Cardiac Rehabilitation Program in Patients With Ischemia With Nonobstructive Coronary Artery Disease (INOCA)
A study testing Telematic cardiac rehabilitation program, that includes exercise, educational and psychological sessions during 3 months and Standard recommendations in people with INOCA (Ischemia With Non Obstructive Coronary Artery Disease), run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- INOCA (Ischemia With Non Obstructive Coronary Artery Disease)
- What is being tested?
- Telematic cardiac rehabilitation program, that includes exercise, educational and psychological sessions during 3 months and Standard recommendations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2024to 15 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: RECOVER WITH INOCA: A Randomized, Prospective Study of a Cardiac Rehabilitation Program in Patients With Ischemia With Nonobstructive Coronary Artery Disease (INOCA)
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?
Read more
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
Read the 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:
- Recruitment: INOCA patients (confirmed diagnosis with microcirculation and provocation testing) are referred from ischemic heart disease consultations.
- 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.
- 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.
- 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.
- Being tested
- Telematic cardiac rehabilitation program, that includes exercise, educational and psychological sessions during 3 months, Standard recommendations
- Keywords
- INOCA, Cardiac rehabilitation, Functional capacity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telematic cardiac rehabilitation program, that includes exercise, educational and psychological sessions during 3 monthsOther
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 recommendationsOther
Standard recommendations about exercise, educational and psychologicla advice
| Study group | Role | What they receive |
|---|---|---|
| Cardiac rehabilitation group (treatment group) | Experimental | 3-mont telematic cardiac rehabilitation program for 3 months, including exercise, educational and psychological sessions Receives: 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 Receives: Other: Standard recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal functional capacity
Change in VO2peak measured with CPET (cardiopulmonary stress test)
Measured: 3 months
Secondary outcomes (6)
EuroQol (EQ-5D)
- Full name: EuroQol Five-Dimension Scale
- Purpose: Measures health-related quality of life (HRQoL) across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. It also includes a visual analogue scale (VAS) for self-rated health.
- Minimum value: 0 (equivalent to death) or negative values (worse than death, depending on country-specific value sets)
- Maximum value: 1 (perfect health)
- Interpretation: Higher scores indicate a better health-related quality of life.
Measured: 3 months
PREDIMED
- Full name: PREDIMED Mediterranean Diet Adherence Screener
- Purpose: Assesses adherence to the Mediterranean diet, which is associated with reduced cardiovascular risk and improved health outcomes.
- Minimum value: 0 (no adherence)
- Maximum value: 14 (maximum adherence)
- Interpretation: Higher scores indicate a better outcome, meaning greater adherence to the Mediterranean diet and its associated health benefits. A score ≥9 suggests high adherence.
Measured: 3 months
HADS
- Full name: Hospital Anxiety and Depression Scale - Depression (HADS-D) and Anxiety (HADS-A) Subscales
- Purpose: Assesses symptoms of anxiety (HADS-A) and depression (HADS-D) in hospital and primary care settings, avoiding somatic symptoms to focus on emotional distress.
- Minimum value: 0 (no symptoms)
- Maximum value: 21 per subscale (total 42 if both are combined)
- Interpretation: Higher scores indicate a worse outcome, meaning more severe anxiety or depression symptoms. Scores of 8-10 suggest mild symptoms, 11-14 moderate, and ≥15 severe symptoms.
Measured: 3 months
Barthel Score
- Full name: Barthel Index of Activities of Daily Living
- Purpose: Evaluates functional independence in activities of daily living (ADLs), such as bathing, dressing, mobility, and feeding, primarily in stroke and rehabilitation patients.
- Minimum value: 0 (total dependence)
- Maximum value: 100 (complete independence)
- Interpretation: Higher scores indicate a better outcome, meaning greater independence in daily activities.
Measured: 3 months
Angina episodes
Change in the number of angina episodes/month
Measured: 3 months
PSQI
- Full name: Pittsburgh Sleep Quality Index
- Purpose: Assesses sleep quality and disturbances over a 1-month period. It consists of 7 components: Subjective sleep quality, Sleep latency, Sleep duration, Habitual sleep efficiency, Sleep disturbances, Use of sleep medication, Daytime dysfunction
- Minimum value: 0 (best sleep quality)
- Maximum value: 21 (worst sleep quality)
- Interpretation: Higher scores indicate a worse outcome, meaning poorer sleep quality. A global PSQI score >5 suggests poor sleep quality.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start1 Sep 2024
- Primary completion15 Dec 2024
- Study completion15 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for INOCA (Ischemia With Non Obstructive Coronary Artery Disease)Studies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Spanish Society of Cardiology
- Responsible party
- Principal investigator, Margarita Calvo, Hospital Clinic of Barcelona
- Investigators
- Margarita Calvo-Lopez, MD, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06887257
- Sponsor's protocol ID
- HCB/2024/0926
- Status last verified
- Mar 2025
- First submitted
- 14 Mar 2025
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD collected throughout the trial
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RECOVER WITH INOCA: A Randomized, Prospective Study of a Cardiac Rehabilitation Program in Patients With Ischemia With Nonobstructive Coronary Artery Disease (INOCA)
- ClinicalTrials.gov ID
- NCT06887257
- Acronym / sponsor ID
- HCB/2024/0926
- Keywords
- INOCA, Cardiac rehabilitation, Functional capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Collaborators
- Spanish Society of Cardiology
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 20 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Recruitment: INOCA patients (confirmed diagnosis with microcirculation and provocation testing) are referred from ischemic heart disease consultations.
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardiac rehabilitation group (treatment group) | Experimental | Other: Telematic cardiac rehabilitation program, that includes exercise, educational and psychological sessions during 3 months3-mont telematic cardiac rehabilitation program for 3 months, including exercise, educational and psychological sessions |
| Standard recommendations (control group) | Active comparator | Other: Standard recommendationsStandard recommendations about exercise, education and psychological advise for INOCA patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telematic cardiac rehabilitation program, that includes exercise, educational and psychological sessions during 3 months2 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. | Other | Cardiac rehabilitation group (treatment group) |
| Standard recommendationsStandard recommendations about exercise, educational and psychologicla advice | Other | Standard recommendations (control group) |
Primary outcome
Maximal functional capacity
Time frame: 3 months
Change in VO2peak measured with CPET (cardiopulmonary stress test)
6 secondary outcomes
EuroQol (EQ-5D)
Time frame: 3 months
PREDIMED
Time frame: 3 months
HADS
Time frame: 3 months
Barthel Score
Time frame: 3 months
Angina episodes
Time frame: 3 months
PSQI
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Individual participant dataSharing planned: Yes. All IPD collected throughout the trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margarita Calvo-Lopez, MD principal investigator
Hospital Clinic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telematic cardiac rehabilitation program, that includes exercise, educational and psychological sessions during 3 months and Standard recommendations in people with INOCA (Ischemia With Non Obstructive Coronary Artery Disease), run by Hospital Clinic of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal functional capacity (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.