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

NCT06597851 | Recruiting

• 1 other identifier: IRIN (225CET)
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Microvascular Dysfunction; Coronary Microvascular Disease; Insulin Resistance

Keywords

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

Outcome Measures

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

  At baseline

Secondary Outcomes (2)

• Correlation in vasomotor function in patients with and without IR

  At baseline

• Adverse clinical events

  12 months

Study Arms (1)

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

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

Interventions

Thermodilution based assessment of coronary microcirculation DIAGNOSTIC_TEST

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

Non-diabetic patients with ANOCA

Hyperinsulinemic-euglycemic Clamp test DIAGNOSTIC_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

Non-diabetic patients with ANOCA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Integrata Verona: lead

Study Sites (1)

Azienda Ospedaliera Universitaria di Verona

Verona, VR, 37126, Italy

RECRUITING

MeSH Terms

Conditions

Microvascular Angina; Insulin Resistance

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Roberto Scarsini MD PhD

  Azienda Ospedaliera Universitaria di Verona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natascia Antonioli

CONTACT

0039 0458122320; studi.clinici.cardiologia@aovr.veneto.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: September 19, 2024
• Study Start: June 24, 2024
• Primary Completion: June 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

IT (1)