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Status unknownNCT06597851IRINUpdated Sep 19, 2024

Insulin Resistance and Coronary Microvascular Dysfunction in Patients with Myocardial Ischemia and Non-obstructive Coronary Artery Disease

An interventional study of Thermodilution based assessment of coronary microcirculation and Hyperinsulinemic-euglycemic Clamp test in Coronary Microvascular Dysfunction, Coronary Microvascular Disease and Insulin Resistance, sponsored by Azienda Ospedaliera Universitaria Integrata Verona. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Azienda Ospedaliera Universitaria Integrata Verona · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Sep 2024), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 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:

  1. Fasting glucose, fasting insulin, HOMA index, glycated haemoglobin and oral glucose tolerance test (OGTT) will be assessed to rule out diabetes.
  2. Transthoracic echocardiography will be performed to evaluate cardiac function and cardiac remodeling.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. Transthoracic echocardiography will be repeated at 12 months.
02

Conditions studied

  • Coronary Microvascular Dysfunction
  • Coronary Microvascular Disease
  • Insulin Resistance

Keywords

  • Coronary Microvascular Dysfunction
  • Coronary Microvascular Disease
  • Insulin Resistance
  • INOCA
  • ANOCA
  • CMD
  • hyperinsulinemic-euglycemic clamp test
03

In context

Microvascular Angina

126 studies on the registry are indexed under Microvascular Angina; 37 are open to participants now.

This study's planned enrollment of 40 is below the median of 70 across 80 interventional studies indexed under Microvascular Angina.

Browse Microvascular Angina studies →

Lead sponsor

Azienda Ospedaliera Universitaria Integrata Verona is the lead sponsor of 94 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Non-diabetic patients with ANOCA

    * Thermodilution based assessment of coronary microcirculation with the derivation of CFR and IMR * Hyperinsulinemic euglycemic clamp for insulin resistance assessment

    Diagnostic Test: Thermodilution based assessment of coronary microcirculation · Diagnostic Test: Hyperinsulinemic-euglycemic Clamp test

Interventions

  • Diagnostic testThermodilution based assessment of coronary microcirculation

    Coronary microvascular assessment with the derivation of CFR, IMR and MRR will be performed using a standard pressure/thermodilution guidewire.

  • Diagnostic testHyperinsulinemic-euglycemic Clamp 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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: At baseline

Secondary outcomes

  1. 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

    Time frame: At baseline

  2. Adverse clinical events

    Composite of cardiovascular death, new hospitalization for HF and/or ACS during follow-up

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
  • Azienda Ospedaliera Universitaria di Verona
    Verona, VR 37126, Italy
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06597851
Lead sponsor
Azienda Ospedaliera Universitaria Integrata Verona
Responsible party
Roberto Scarsini (Principal Investigator, Azienda Ospedaliera Universitaria Integrata Verona) — Principal investigator
First posted
Sep 19, 2024
Start date
Jun 24, 2024
Primary completion
Jun 30, 2025 (estimated)
Completion
Jun 30, 2026 (estimated)
Last update
Sep 19, 2024

Study contacts

Natascia Antonioli
Contact
studi.clinici.cardiologia@aovr.veneto.it
0039 0458122320
Roberto Scarsini MD PhD
principal investigator · Azienda Ospedaliera Universitaria di Verona

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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