Assessing insulin resistance and coronary microvascular dysfunction in patients with non-obstructive coronary artery disease
Insulin Resistance and Coronary Microvascular Dysfunction in Patients with Myocardial Ischemia and Non-obstructive Coronary Artery Disease
This study is testing how insulin resistance affects heart blood flow in people with non-obstructive coronary artery disease to see if there's a connection between the two.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Azienda Ospedaliera Universitaria Integrata Verona Academic / other |
| Locations | 1 site (Verona, VR) |
| Trial ID | NCT06597851 on ClinicalTrials.gov |
What this trial studies
This prospective study aims to evaluate the relationship between coronary microvascular dysfunction and insulin resistance in patients diagnosed with ischemia and non-obstructive coronary artery disease (INOCA). Eligible participants will undergo a series of diagnostic tests, including coronary angiography and hyperinsulinemic-euglycemic clamp tests, to assess their condition. The study will follow participants for two years to monitor their clinical outcomes and gather data on the correlation between these two conditions.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years experiencing cardiac chest pain with evidence of myocardial ischemia but without obstructive coronary artery disease.
Not a fit: Patients with obstructive coronary artery disease, a history of myocardial infarction, or type II diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of coronary microvascular dysfunction in patients with insulin resistance.
How similar studies have performed: While the specific correlation between insulin resistance and coronary microvascular dysfunction in this context is less explored, similar studies have shown promising results in related areas.
Eligibility criteria
Show full inclusion / exclusion criteria
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: * 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.
Where this trial is running
Verona, VR
- Azienda Ospedaliera Universitaria di Verona — Verona, Vr, Italy (Recruiting)
Study contacts
- Principal investigator: Roberto Scarsini MD PhD — Azienda Ospedaliera Universitaria di Verona
- Study coordinator: Natascia Antonioli
- Email: studi.clinici.cardiologia@aovr.veneto.it
- Phone: 0039 0458122320
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.