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

Sponsor
Azienda Ospedaliera Universitaria Integrata Verona
Study ID
NCT06597851
Status
Recruiting
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Conditions

  • Coronary Microvascular Disease
  • Coronary Microvascular Dysfunction
  • Insulin Resistance

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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

Study Details

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.

Key Dates

First listed
Sep 19, 2024
Start date
Jun 24, 2024
Status verified
Sep 2024
Primary completion
Jun 30, 2025
Completion
Jun 30, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

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

Primary Outcome Measure

Correlation between coronary microvascular dysfunction and insulin resistance [ Time Frame: At baseline ]

Central Contacts

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