Coronary Microvascular DiseaseExINOCANCT06529848
Impact of Exercise Training on Ischemia With Non-Obstructive Coronary Arteries (INOCA): The ExINOCA Study
A study testing Exercise training in people with Coronary Microvascular Disease and CMD, run by Bispebjerg Hospital at 2 sites in Denmark.
Trial summary
The purpose of the study is to identify causes of chest pain in patients experiencing chest pain with no signs of narrowing of the coronary arteries of the heart, and to investigate whether physical exercise can improve coronary microvascular function. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Coronary Microvascular Disease, CMD
- What is being tested?
- Exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Nov 2024to 15 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Coronary microvascular dysfunction, defined as myocardial bloodflow reserve (MBFR) < 2.5 or hyperemic myocar-dial blood flow (hMBF)<2.3 ml/g/min using [15O]H2O-PET
- No obstructive coronary artery disease
Who cannot join
- Females of childbearing potential (defined as a premeno-pausal female capable of becoming pregnant). The female patient must either be postmenopausal, defined as amen-orrhea for at least 1 year, or surgically sterile
- Heart failure, defined as left ventricular ejection fraction of less than 40%
- Uncontrolled hypertension defined as blood pressure above target 140/90 for all
- Co-morbidity resulting in <1 year expected survival
- Considered by the investigator, for any reason, to be an un-suitable candidate for the study.
- Unable or unwilling to exercise, e.g. due to arthritis or in-jury*
- Already are regularly physically active and/or have a maxi-mal oxygen uptake >45 ml/kg/min
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark2 sites, 2 recruiting
- Not yet recruiting
Frederiksberg Hospital, Dept. of Cardiology, Building 16, Y3, Nordre Fasanvej 57, Frederiksberg, Denmark, 2000
Copenhagen, 2400
Eva Prescott, MD, DMSc, +45 4026 2134, Eva.Irene.Bossano.Prescott@regionh.dk
Mads Fischer, MSc, +4524485450, mf@nexs.ku.dk
- Recruiting
Frederiksberg Hospital, Dept. of Cardiology, Building 16, Y3, Nordre Fasanvej 57
Frederiksberg, 2000
Eva Prescott, MD, DMSc, +45 4026 2134, Eva.Irene.Bossano.Prescott@regionh.dk
Mads Fischer, MSc, +4524485450, mf@nexs.ku.dk
About this study
Official title: Ischemia With No Obstruction of Coronary Arteries: Underlying Mechanisms and the Impact of Exercise Training (EXINOCA)
The purpose of the study is to identify causes of chest pain in patients experiencing chest pain with no signs of narrowing of the coronary arteries of the heart, and to investigate whether physical exercise can improve coronary microvascular function.
Hypotheses:
The first hypothesis is that in INOCA, with reduced function of microvasculature of the heart, this reduced function also occurs in other organs of the body.
The second hypothesis is that regular physical activity (aerobic exercise training) can improve coronary microvascular function, reduce symptoms, and that there is a parallel improvement in vascular function in other organs of the body.
Read the detailed description
A significant number of patients suspected of chronic coronary syndrome do not have coronary artery obstruction and in a large proportion of these, their symptoms are attributed to coronary microvascular dysfunction (CMD), a condition known as ischemia with no obstructive coronary artery disease (INOCA). Despite a considerable patient population affected by INOCA, the specific mechanisms underlying CMD are not fully understood, often resulting in a lack of targeted treatment. There is evidence to suggest that exercise capacity is linked to coronary microvascular function, positing that exercise training could potentially reverse microvascular dysfunction and address its mechanistic origins, a hypothesis yet to be explored.
This study aims to identify mechanisms underlying CMD in angina and to assess whether exercise training can improve the condition.
The current study is a randomized controlled trial testing the effect of exercise training in patients with CMD. 100 patients will be randomized 1:1 to exercise training or control. The primary outcome is coronary microvascular function, secondary outcomes include symptoms and microvascular function in cutaneous tissue, skeletal muscle, and adipose tissue.
- Conditions
- Coronary Microvascular Disease, CMD
- Being tested
- Exercise training
- Medical subject headings
- Microvascular Angina
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingOther
Also called Physical activity, Endurance training
The training sessions are consist of cycling and as follows: a 10 min warm-up at a light intensity, 20-35 min of cycling exercise in intervals at varying intensities from light (~60% of max heart rate) to more intensive (80-90% of max heart rate) and ending with 5 min of warm-down at a light intensity. The training intensity will be progressive during the course of the intervention period. The cycling training sessions are supervised .
Home training is allowed up to once a week if participants are able to adhere to the prescribed intensity levels.
Training sessions are closely monitored to ensure effectiveness and safety. This includes heart rate monitoring, perceived exertion assessment.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Active comparator | The exercise intervention consists of supervised training 40-50 minutes x 3 weekly for 12 weeks. Receives: Other: Exercise training |
| Control | No intervention | The participants who are randomized to the no-training group will be offered exercise train-ing after the intervention is completed. Participants will be encouraged to not change their lifestyle or medication throughout the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Myocardial Blood Flow Reserve (MBFR)
Change in MBFR assessed by [15O]H2O-PET-scan
Measured: From baseline and after 3 months
Secondary outcomes (4)
Change in symptom burden assessed by Seattle Angina Questionnaire
Seattle angina questionnaire/selfreported (scale range 0-100, 0=poor and 100=excellent health status)
Measured: From baseline and after 3 months
Change in exercise capacity
Oxygen uptake during exhaustive exercise
Measured: From baseline and after 3 months
Change in global rest perfusion in patients with angina symptoms and CMD
Change in Myocardial Blood Flow assessed by [15O]H2O-PET-scan
Measured: From baseline and after 3 months
Change in global stress perfusion in patients with angina symptoms and CMD
Change in hyperemic Myocardial Blood Flow assessed by [15O]H2O-PET-scan
Measured: From baseline and after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start1 Nov 2024
- Primary completion30 Oct 2027 (estimated)
- Study completion15 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Microvascular DiseaseStudies of the same condition, open and under way.
- 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
- Model description
- Randomized controlled trial in which 100 angina patients with reduced flow reserve (INOCA patients) are randomized 1:1 to either exercise training or control (no exer-cise training).
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Principal investigator, Eva Prescott, Bispebjerg Hospital
- Investigators
- Eva Prescott, MD, DMSc, Principal investigator, University of CopenhagenYlva Hellsten, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06529848
- Sponsor's protocol ID
- ExINOCA
- Acronym
- ExINOCA
- Status last verified
- Feb 2025
- First submitted
- 4 Jul 2024
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ischemia With No Obstruction of Coronary Arteries: Underlying Mechanisms and the Impact of Exercise Training (EXINOCA)
- ClinicalTrials.gov ID
- NCT06529848
- Acronym / sponsor ID
- ExINOCA / ExINOCA
- Conditions
- Coronary Microvascular Disease, CMD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 15 May 2028 (estimated)
- First posted
- 31 Jul 2024 (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 purpose of the study is to identify causes of chest pain in patients experiencing chest pain with no signs of narrowing of the coronary arteries of the heart, and to investigate whether physical exercise can improve coronary microvascular function.
Hypotheses:
The first hypothesis is that in INOCA, with reduced function of microvasculature of the heart, this reduced function also occurs in other organs of the body.
The second hypothesis is that regular physical activity (aerobic exercise training) can improve coronary microvascular function, reduce symptoms, and that there is a parallel improvement in vascular function in other organs of the body.
Detailed description
A significant number of patients suspected of chronic coronary syndrome do not have coronary artery obstruction and in a large proportion of these, their symptoms are attributed to coronary microvascular dysfunction (CMD), a condition known as ischemia with no obstructive coronary artery disease (INOCA). Despite a considerable patient population affected by INOCA, the specific mechanisms underlying CMD are not fully understood, often resulting in a lack of targeted treatment. There is evidence to suggest that exercise capacity is linked to coronary microvascular function, positing that exercise training could potentially reverse microvascular dysfunction and address its mechanistic origins, a hypothesis yet to be explored.
This study aims to identify mechanisms underlying CMD in angina and to assess whether exercise training can improve the condition.
The current study is a randomized controlled trial testing the effect of exercise training in patients with CMD. 100 patients will be randomized 1:1 to exercise training or control. The primary outcome is coronary microvascular function, secondary outcomes include symptoms and microvascular function in cutaneous tissue, skeletal muscle, and adipose tissue.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial in which 100 angina patients with reduced flow reserve (INOCA patients) are randomized 1:1 to either exercise training or control (no exer-cise training).
| Arm | Type | Receives |
|---|---|---|
| Exercise | Active comparator | Other: Exercise trainingThe exercise intervention consists of supervised training 40-50 minutes x 3 weekly for 12 weeks. |
| Control | No intervention | –The participants who are randomized to the no-training group will be offered exercise train-ing after the intervention is completed. Participants will be encouraged to not change their lifestyle or medication throughout the study period. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Coronary microvascular dysfunction, defined as myocardial bloodflow reserve (MBFR) < 2.5 or hyperemic myocar-dial blood flow (hMBF)<2.3 ml/g/min using [15O]H2O-PET
- No obstructive coronary artery disease
Key exclusion criteria (7 listed)
- Females of childbearing potential (defined as a premeno-pausal female capable of becoming pregnant). The female patient must either be postmenopausal, defined as amen-orrhea for at least 1 year, or surgically sterile
- Heart failure, defined as left ventricular ejection fraction of less than 40%
- Uncontrolled hypertension defined as blood pressure above target 140/90 for all
- Co-morbidity resulting in <1 year expected survival
- Considered by the investigator, for any reason, to be an un-suitable candidate for the study.
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 |
|---|---|---|
| Exercise trainingAlso: Physical activity, Endurance trainingThe training sessions are consist of cycling and as follows: a 10 min warm-up at a light intensity, 20-35 min of cycling exercise in intervals at varying intensities from light (~60% of max heart rate) to more intensive (80-90% of max heart rate) and ending with 5 min of warm-down at a light intensity. The training intensity will be progressive during the course of the intervention period. The cycling training sessions are supervised . Home training is allowed up to once a week if participants are able to adhere to the prescribed intensity levels. Training sessions are closely monitored to ensure effectiveness and safety. This includes heart rate monitoring, perceived exertion assessment. | Other | Exercise |
Primary outcome
Change in Myocardial Blood Flow Reserve (MBFR)
Time frame: From baseline and after 3 months
Change in MBFR assessed by [15O]H2O-PET-scan
4 secondary outcomes
Change in symptom burden assessed by Seattle Angina Questionnaire
Time frame: From baseline and after 3 months
Change in exercise capacity
Time frame: From baseline and after 3 months
Change in global rest perfusion in patients with angina symptoms and CMD
Time frame: From baseline and after 3 months
Change in global stress perfusion in patients with angina symptoms and CMD
Time frame: From baseline and after 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Coronary Microvascular Disease
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The Role of CD34+ Stem Cells in the Pathogenesis of Takotsubo Syndrome
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Invasive Evaluation and Phenotype-Guided Treatment of ANOCA in Women
ANOCA - Angina With Non-obstructive Coronary Arteries, Coronary Microvascular Dysfunction (CMD)
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Mechanical Dyssynchrony and Microvascular Dysfunction by SPECT
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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.
Eva Prescott, MD, DMSc principal investigator
University of Copenhagen
Ylva Hellsten principal investigator
University of Copenhagen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training in people with Coronary Microvascular Disease and CMD, run by Bispebjerg Hospital at 2 sites in Denmark.
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 2 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eva Prescott, MD, DMSc (004522572614, Eva.Irene.Bossano.Prescott@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Myocardial Blood Flow Reserve (MBFR) (time frame: From baseline and after 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 21 Feb 2025.