Coronary Microvascular DysfunctionIRINNCT06597851
Insulin Resistance and Coronary Microvascular Dysfunction in Patients With Myocardial Ischemia and Non-obstructive Coronary Artery Disease
A study testing Thermodilution based assessment of coronary microcirculation and Hyperinsulinemic-euglycemic Clamp test in people with Coronary Microvascular Dysfunction and Coronary Microvascular Disease, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
Trial summary
The goal of this prospective study is to assess the correlation between coronary microvascular disfunction and insulin resistance in patients with INOCA. Patients with ANOCA and without diabetes will undergo invasive coronary microvascular assessment through coronary angiography and insulin resistance assessment… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Microvascular Dysfunction, Coronary Microvascular Disease, Insulin Resistance
- What is being tested?
- Thermodilution based assessment of coronary microcirculation and Hyperinsulinemic-euglycemic Clamp test
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 24 Jun 2024to 30 Jun 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged over 18 years.
- Cardiac chest pain with evidence of myocardial ischemia at noninvasive myocardial stress imaging and clinical indication to diagnostic coronary angiography
- Willing and able to give informed consent for participation in the study
Who cannot join
- Obstructive CAD (defined as more than 70% luminal stenosis and/or FFR ≤0.80 in 1 or more epicardial vessels).
- History of previous myocardial infarction, percutaneous revascularization or coronary-aortic bypass graft (CABG) surgery.
- Diagnosis of type II diabetes.
- BMI ≥ 35 kg/m2.
- Stage IV and V of chronic kidney disease (eGFR ≤ 30 ml/min, estimated through CKD - EPI Creatinine Equation).
- Allergy or other contraindication to iodinated contrast and/or gadolinium and/or adenosine.
- Chronic resting O2 saturation ≤ 85%.
- Pregnancy or suspected pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this prospective study is to assess the correlation between coronary microvascular disfunction and insulin resistance in patients with INOCA.
Patients with ANOCA and without diabetes will undergo invasive coronary microvascular assessment through coronary angiography and insulin resistance assessment through hyperinsulinemic-euglycemic clamp test.
Patients enrolled in the study will be followed for a period of 2 years to monitor their clinical status.
Read the detailed description
This is a prospective, experimental, single-center, explorative study designed to assess the correlation between coronary microvascular disfunction and insulin resistance in patients with INOCA.
Patients identified as eligible for the protocol will be asked for written informed consent to participate in the study.
Participants will undergo multimodality diagnostic tests as per standard clinical practice and international recommendations:
- Fasting glucose, fasting insulin, HOMA index, glycated haemoglobin and oral glucose tolerance test (OGTT) will be assessed to rule out diabetes.
- Transthoracic echocardiography will be performed to evaluate cardiac function and cardiac remodeling.
- Coronary angiography will be performed to rule out obstructive CAD defined as angiographic stenosis ≥ 70% of one or more main epicardial coronary arteries (defined as vessels with diameter >2.0 mm) and/or fractional flow reserve (FFR) ≤ 0,80 as indicated by the latest European Guidelines.
- In case of angiographic evidence of unobstructive CAD, participants will undergo coronary microvascular function assessment using standard coronary pressure guidewire as indicated by the latest European Guidelines according to the recently described Fullphysiology method. If clinically indicated, in case of suspected epicardial or microvascular spasm, endothelial-dependent vasomotor function will be evaluated using a standard vasoreactivity test based on incremental doses of acetylcoline infusion as indicated by the latest European Guidelines.
- Patients will undergo hyperinsulinemic-euglycemic clamp test at Diabetology Unit of AOUI Verona to evaluate insulin resistance and the metabolic risk. In patients with no clinical concerns, adequate pharmacological washout from betablockers, ace inhibitors, sartans and/or calcium antagonists will be considered before performing the clamp test.
- Patients will undergo clinical follow up at 6 and 12 months via outpatient clinic or telephone contacts. Fasting glucose, fasting insulin, HOMA index and glycated haemoglobin will be re-assessed at 12 months.
- Transthoracic echocardiography will be repeated at 12 months.
- Being tested
- Thermodilution based assessment of coronary microcirculation, Hyperinsulinemic-euglycemic Clamp test
- Keywords
- Coronary Microvascular Dysfunction, Coronary Microvascular Disease, Insulin Resistance, INOCA, ANOCA, CMD, hyperinsulinemic-euglycemic clamp test
- Medical subject headings
- Microvascular Angina, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermodilution based assessment of coronary microcirculationDiagnostic test
Coronary microvascular assessment with the derivation of CFR, IMR and MRR will be performed using a standard pressure/thermodilution guidewire.
Hyperinsulinemic-euglycemic Clamp testDiagnostic test
Infusion of insulin and glucose adjusting rate of glucose infusion to maintaine plasma glucose around 90 mg/dL by monitoring plasma glucose levels every 5-10 minutes
| Study group | Role | What they receive |
|---|---|---|
| Non-diabetic patients with ANOCA | Experimental | * Thermodilution based assessment of coronary microcirculation with the derivation of CFR and IMR
* Hyperinsulinemic euglycemic clamp for insulin resistance assessment Receives: Diagnostic Test: Thermodilution based assessment of coronary microcirculation; Diagnostic Test: Hyperinsulinemic-euglycemic Clamp test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between coronary microvascular dysfunction and insulin resistance
Correlation between the index of microcirculatory resistance (IMR) and the M-value evaluated with the hyperinsulinemic-euglycemic clamp test as a measure of insulin resistance
Measured: At baseline
Secondary outcomes (2)
Correlation in vasomotor function in patients with and without IR
Difference in vasomotor dysfunction at vasoreactivity test with acetylcholine in patients with and without IR
Measured: At baseline
Adverse clinical events
Composite of cardiovascular death, new hospitalization for HF and/or ACS during follow-up
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start24 Jun 2024
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Jun 2027 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, experimental, single-arm, explorative study. The study aims to perform a functional study of the coronary microcirculation with pressure guides, in patients with angina and non obstructive coronary artery disease. Also a tranthoracic echocardiography will be performed. Following this, the patient will undergo hyperinsulinemic-euglycemic clamp test to evaluate insulin resistance and the metabolic risk. The primary endpoint is to assess the correlation between the index of microcirculatory resistance and the M-value evaluated with clamp test as a measure of insulin resistance. Follow up will continue up to 1 year from enrollment through telephone contacts, outpatient visits and review of clinical data.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Scarsini, Azienda Ospedaliera Universitaria Integrata Verona
- Investigators
- Roberto Scarsini MD PhD, Principal investigator, Azienda Ospedaliera Universitaria di Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06597851
- Sponsor's protocol ID
- IRIN (225CET)
- Acronym
- IRIN
- Status last verified
- Oct 2026
- First submitted
- 12 Sep 2024
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin Resistance and Coronary Microvascular Dysfunction in Patients With Myocardial Ischemia and Non-obstructive Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT06597851
- Acronym / sponsor ID
- IRIN / IRIN (225CET)
- Keywords
- Coronary Microvascular Dysfunction, Coronary Microvascular Disease, Insulin Resistance, INOCA, ANOCA, CMD, hyperinsulinemic-euglycemic clamp test
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata VeronaUniversity, hospital or other
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 19 Sep 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 goal of this prospective study is to assess the correlation between coronary microvascular disfunction and insulin resistance in patients with INOCA.
Patients with ANOCA and without diabetes will undergo invasive coronary microvascular assessment through coronary angiography and insulin resistance assessment through hyperinsulinemic-euglycemic clamp test.
Patients enrolled in the study will be followed for a period of 2 years to monitor their clinical status.
Detailed description
This is a prospective, experimental, single-center, explorative study designed to assess the correlation between coronary microvascular disfunction and insulin resistance in patients with INOCA.
Patients identified as eligible for the protocol will be asked for written informed consent to participate in the study.
Participants will undergo multimodality diagnostic tests as per standard clinical practice and international recommendations:
- Fasting glucose, fasting insulin, HOMA index, glycated haemoglobin and oral glucose tolerance test (OGTT) will be assessed to rule out diabetes.
- Transthoracic echocardiography will be performed to evaluate cardiac function and cardiac remodeling.
- Coronary angiography will be performed to rule out obstructive CAD defined as angiographic stenosis ≥ 70% of one or more main epicardial coronary arteries (defined as vessels with diameter >2.0 mm) and/or fractional flow reserve (FFR) ≤ 0,80 as indicated by the latest European Guidelines.
- In case of angiographic evidence of unobstructive CAD, participants will undergo coronary microvascular function assessment using standard coronary pressure guidewire as indicated by the latest European Guidelines according to the recently described Fullphysiology method. If clinically indicated, in case of suspected epicardial or microvascular spasm, endothelial-dependent vasomotor function will be evaluated using a standard vasoreactivity test based on incremental doses of acetylcoline infusion as indicated by the latest European Guidelines.
- Patients will undergo hyperinsulinemic-euglycemic clamp test at Diabetology Unit of AOUI Verona to evaluate insulin resistance and the metabolic risk. In patients with no clinical concerns, adequate pharmacological washout from betablockers, ace inhibitors, sartans and/or calcium antagonists will be considered before performing the clamp test.
- Patients will undergo clinical follow up at 6 and 12 months via outpatient clinic or telephone contacts. Fasting glucose, fasting insulin, HOMA index and glycated haemoglobin will be re-assessed at 12 months.
- Transthoracic echocardiography will be repeated at 12 months.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, experimental, single-arm, explorative study. The study aims to perform a functional study of the coronary microcirculation with pressure guides, in patients with angina and non obstructive coronary artery disease. Also a tranthoracic echocardiography will be performed. Following this, the patient will undergo hyperinsulinemic-euglycemic clamp test to evaluate insulin resistance and the metabolic risk. The primary endpoint is to assess the correlation between the index of microcirculatory resistance and the M-value evaluated with clamp test as a measure of insulin resistance. Follow up will continue up to 1 year from enrollment through telephone contacts, outpatient visits and review of clinical data.
| Arm | Type | Receives |
|---|---|---|
| Non-diabetic patients with ANOCA | Experimental | Diagnostic Test: Thermodilution based assessment of coronary microcirculation, Diagnostic Test: Hyperinsulinemic-euglycemic Clamp test* Thermodilution based assessment of coronary microcirculation with the derivation of CFR and IMR * Hyperinsulinemic euglycemic clamp for insulin resistance assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged over 18 years.
- Cardiac chest pain with evidence of myocardial ischemia at noninvasive myocardial stress imaging and clinical indication to diagnostic coronary angiography
- Willing and able to give informed consent for participation in the study
Key exclusion criteria (8 listed)
- Obstructive CAD (defined as more than 70% luminal stenosis and/or FFR ≤0.80 in 1 or more epicardial vessels).
- History of previous myocardial infarction, percutaneous revascularization or coronary-aortic bypass graft (CABG) surgery.
- Diagnosis of type II diabetes.
- BMI ≥ 35 kg/m2.
- Stage IV and V of chronic kidney disease (eGFR ≤ 30 ml/min, estimated through CKD - EPI Creatinine Equation).
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 |
|---|---|---|
| Thermodilution based assessment of coronary microcirculationCoronary microvascular assessment with the derivation of CFR, IMR and MRR will be performed using a standard pressure/thermodilution guidewire. | Diagnostic test | Non-diabetic patients with ANOCA |
| Hyperinsulinemic-euglycemic Clamp testInfusion of insulin and glucose adjusting rate of glucose infusion to maintaine plasma glucose around 90 mg/dL by monitoring plasma glucose levels every 5-10 minutes | Diagnostic test | Non-diabetic patients with ANOCA |
Primary outcome
Correlation between coronary microvascular dysfunction and insulin resistance
Time frame: At baseline
Correlation between the index of microcirculatory resistance (IMR) and the M-value evaluated with the hyperinsulinemic-euglycemic clamp test as a measure of insulin resistance
2 secondary outcomes
Correlation in vasomotor function in patients with and without IR
Time frame: At baseline
Adverse clinical events
Time frame: 12 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 27 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
Roberto Scarsini MD PhD principal investigator
Azienda Ospedaliera Universitaria di Verona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thermodilution based assessment of coronary microcirculation and Hyperinsulinemic-euglycemic Clamp test in people with Coronary Microvascular Dysfunction and Coronary Microvascular Disease, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
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 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: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. 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 Italy. 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?
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?
Correlation between coronary microvascular dysfunction and insulin resistance (time frame: At baseline). 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 27 Oct 2026.