Health TrialsbyHealthPanel

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

ConditionsCoronary Microvascular DysfunctionCoronary Microvascular DiseaseInsulin Resistance
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAzienda Ospedaliera Universitaria Integrata Verona

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Non-diabetic patients with ANOCAExperimental treatment 2 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Azienda Ospedaliera Universitaria Integrata Verona

Lead sponsor

Source ClinicalTrials.gov
Apply now