Coronary Microvascular DysfunctionExINOCA-P1NCT06529861
Mechanisms Behind Microvascular Dysfunction in INOCA
An observational study of Coronary Microvascular Dysfunction and Ischaemia With Non Obstructed Coronary Arteries, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
The purpose of the study is to identify the causes of chest pain in patients experiencing chest pain with no signs of narrowing in the coronary arteries of the heart. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Microvascular Dysfunction, Ischaemia With Non Obstructed Coronary Arteries
- What is being tested?
- [15O]H2O-PET Imaging
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2024to 15 May 2028
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Ischemia with no obstruction of coronary arteries (INOCA) is estimated to affect >150.000 Danes and the majority are females. These patients have a shorter life expectancy than age matched controls and a higher incidence of major cardiovascular events (1,2). INOCA is caused by microvascular dysfunction. When there is dysfunction in the microvascu-lature, the blood flow within the coronary vessels fails to increase adequately to meet the de-mand, resulting in ischemia and pain (angina).
Who may be able to join
- Only for angina patients: Have CMD, defined as myocardial bloodflow re-serve (MBFR) < 2.5 or hyperemic myocardial blood flow (hMBF) < 2.3ml/g/min
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 unsuitable candidate for the study.
- Unable or unwilling to exercise, e.g. due to arthritis or injury*
- Already are regularly physically active and/or have a maximal oxygen uptake >45 ml/kg/min
- The subject has a known allergy to either: norepinephrine, adenosine, ketorolac, and or ascorbic acid (vitamin C).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site
Frederiksberg Hospital, Dept. of Cardiology, Building 16, Y3, Nordre Fasanvej 57, Frederiksberg, Denmark, 2000
Copenhagen, 2400
About this study
Official title: Identification of Mechanisms Behind Microvascular Dysfunction in Ischemia With No Obstructive Coronary Artery Disease
The purpose of the study is to identify the causes of chest pain in patients experiencing chest pain with no signs of narrowing in the coronary arteries of the heart.
Read the detailed description
A significant number of patients with ischemic heart disease do not exhibit coronary obstruction, leading to their symptoms being attributed to coronary microvascular dysfunction, a condition known as ischemia with no obstructive coronary artery disease (INOCA). Despite a considerable patient population affected by INOCA, the specific mechanisms underlying this microvascular dysfunction 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, an area yet to be explored.
This study aims to identify mechanisms underlying Coronary microvascular dysfunction (CMD) in angina and to assess whether exercise training can improve the condition. In study part I 30 patients with impaired coronary microvascular function and 30 asymptomatic controls will be studied to identify vascular and related molecular mechanisms underlying INOCA by investigating microvascular function in the heart and in cutaneous tissue, skeletal muscle, and adipose tissue.
- Being tested
- [15O]H2O-PET Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[15O]H2O-PET ImagingDiagnostic test
This imaging technique will be used to measure myocardial blood flow (MBF) and myocardial blood flow reserve (MBFR) in patients. The PET-CT scan involves the use of the radioactive tracer [15O]H2O to visualize blood flow in the heart, providing crucial data on coronary microvascular function.
| Study group | Role | What they receive |
|---|---|---|
| Ischemia and no obstructive coronary arteries | patients with angina and reduced myocardial blood flow reserve Receives: Diagnostic Test: [15O]H2O-PET Imaging | |
| Control | controls without angina Receives: Diagnostic Test: [15O]H2O-PET Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular function in response to acetylcholine stress
Vascular conductance measured by ultrasound doppler during infusion of acetylcholine
Measured: Baseline only
Secondary outcomes (11)
Vascular function in response to acetylcholine adenosine stress
Vascular conductance measured by ultrasound doppler during infusion of Adenosine
Measured: Baseline only
Myocardial Blood flow reserve
Determined by the clinical assessment of [15O]H2O-PET
Measured: Baseline only
Skeletal Muscle Microvascular Function
Evaluated by brachial artery ultrasound Doppler in response to exercise stress to measure blood flow responsiveness in skeletal muscles.
Measured: Baseline only
Changes in isolated small artery reactivity assessed with myography
Analyzed using myograph to study the tone of smooth muscle cells
Measured: Baseline only
Arterial Compliance
Determined by calculations made from intra-arterial pressure and arterial diameter measurements obtained via ultrasound Doppler to assess arterial compliance.
Measured: Baseline only
Plasma Lipids
Conducted through clinical chemical analysis to measure levels of HDL, and triglycerides in the blood, providing insights into lipid profiles.
Measured: Baseline only
Plasma HbA1c
Conducted through clinical chemical analysis to measure levels of HbA1c in the blood, providing insights into glucose metabolism.
Measured: Baseline only
Plasma Levels of Markers Related to Vascular Function
Assessed using Mesoscale/ELISA to quantify biomarkers associated with vascular function
Measured: Baseline only
Plasma Levels of Inflammatory Markers
Measured using Mesoscale/ELISA/O-Link platforms to evaluate the presence and levels of inflammatory markers
Measured: Baseline only
Arterial Blood Pressure
Monitored with automated blood pressure measurements at rest and during exercise to assess overall cardiovascular health and response to physical activity.
Measured: Baseline only
Cardiac Function
Changes in stroke volume using echocardiography during rest and exercise stress
Measured: Baseline only
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 Oct 2024 (estimated)
- 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 DysfunctionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 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
- Ylva Hellsten, Professor, Study chair, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06529861
- Sponsor's protocol ID
- ExINOCA - Part I
- Acronym
- ExINOCA-P1
- Status last verified
- Jul 2024
- First submitted
- 8 Jul 2024
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Mechanisms Behind Microvascular Dysfunction in Ischemia With No Obstructive Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT06529861
- Acronym / sponsor ID
- ExINOCA-P1 / ExINOCA - Part I
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- 1 Oct 2024 (estimated)
- 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 the causes of chest pain in patients experiencing chest pain with no signs of narrowing in the coronary arteries of the heart.
Detailed description
A significant number of patients with ischemic heart disease do not exhibit coronary obstruction, leading to their symptoms being attributed to coronary microvascular dysfunction, a condition known as ischemia with no obstructive coronary artery disease (INOCA). Despite a considerable patient population affected by INOCA, the specific mechanisms underlying this microvascular dysfunction 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, an area yet to be explored.
This study aims to identify mechanisms underlying Coronary microvascular dysfunction (CMD) in angina and to assess whether exercise training can improve the condition. In study part I 30 patients with impaired coronary microvascular function and 30 asymptomatic controls will be studied to identify vascular and related molecular mechanisms underlying INOCA by investigating microvascular function in the heart and in cutaneous tissue, skeletal muscle, and adipose tissue.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ischemia and no obstructive coronary arteries | – | Diagnostic Test: [15O]H2O-PET Imagingpatients with angina and reduced myocardial blood flow reserve |
| Control | – | Diagnostic Test: [15O]H2O-PET Imagingcontrols without angina |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Ischemia with no obstruction of coronary arteries (INOCA) is estimated to affect >150.000 Danes and the majority are females. These patients have a shorter life expectancy than age matched controls and a higher incidence of major cardiovascular events (1,2). INOCA is caused by microvascular dysfunction. When there is dysfunction in the microvascu-lature, the blood flow within the coronary vessels fails to increase adequately to meet the de-mand, resulting in ischemia and pain (angina).
Key inclusion criteria (1 listed)
- Only for angina patients: Have CMD, defined as myocardial bloodflow re-serve (MBFR) < 2.5 or hyperemic myocardial blood flow (hMBF) < 2.3ml/g/min
Key exclusion criteria (8 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 unsuitable 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 |
|---|---|---|
| [15O]H2O-PET ImagingThis imaging technique will be used to measure myocardial blood flow (MBF) and myocardial blood flow reserve (MBFR) in patients. The PET-CT scan involves the use of the radioactive tracer [15O]H2O to visualize blood flow in the heart, providing crucial data on coronary microvascular function. | Diagnostic test | Control, Ischemia and no obstructive coronary arteries |
Primary outcome
Vascular function in response to acetylcholine stress
Time frame: Baseline only
Vascular conductance measured by ultrasound doppler during infusion of acetylcholine
11 secondary outcomes
Vascular function in response to acetylcholine adenosine stress
Time frame: Baseline only
Myocardial Blood flow reserve
Time frame: Baseline only
Skeletal Muscle Microvascular Function
Time frame: Baseline only
Changes in isolated small artery reactivity assessed with myography
Time frame: Baseline only
Arterial Compliance
Time frame: Baseline only
Plasma Lipids
Time frame: Baseline only
Plasma HbA1c
Time frame: Baseline only
Plasma Levels of Markers Related to Vascular Function
Time frame: Baseline only
Plasma Levels of Inflammatory Markers
Time frame: Baseline only
Arterial Blood Pressure
Time frame: Baseline only
Cardiac Function
Time frame: Baseline only
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 31 Jul 2024.
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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.
Ylva Hellsten, Professor study chair
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Microvascular Dysfunction and Ischaemia With Non Obstructed Coronary Arteries, run by Bispebjerg Hospital at 1 site 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 1 inclusion and 8 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: opening soon, as of the sponsor's last update on 31 Jul 2024. 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 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 (22572614, 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?
Vascular function in response to acetylcholine stress (time frame: Baseline only). 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 31 Jul 2024.