Actively Recruiting
Insulin Resistance and Coronary Microvascular Dysfunction in Patients with Myocardial Ischemia and Non-obstructive Coronary Artery Disease
Led by Azienda Ospedaliera Universitaria Integrata Verona · Updated on 2024-09-19
40
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the relationship between coronary microvascular dysfunction and insulin resistance in adults with myocardial ischemia but without obstructive coronary artery disease (INOCA). This prospective, experimental study aims to explore how these conditions may be connected in patients without diabetes. Participants will be followed for two years to monitor their health outcomes and clinical status. Participants will undergo a series of diagnostic tests including coronary angiography to assess their coronary arteries and exclude obstructive disease. Those with non-obstructive findings will have their coronary microvascular function evaluated using thermodilution methods. Insulin resistance will be measured through a hyperinsulinemic-euglycemic clamp test. Additional assessments include echocardiography, fasting glucose and insulin tests, HOMA index, glycated hemoglobin, and oral glucose tolerance tests. Follow-up visits will occur at 6 and 12 months with some tests repeated to monitor changes. Throughout the study, participants will have clinical evaluations, blood tests, and heart function imaging to track their condition. Researchers will measure the correlation between coronary microvascular dysfunction and insulin resistance at the start, assess vasomotor function, and record any adverse clinical events over 12 months. Safety and health status will be monitored regularly, with follow-up continuing for two years to better understand the progression and interaction of these conditions.
CONDITIONS
Brief Title
Insulin Resistance and Coronary Microvascular Dysfunction in Patients with Myocardial Ischemia and Non-obstructive Coronary Artery Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged over 18 years
- Experiencing cardiac chest pain with evidence of myocardial ischemia on noninvasive stress imaging
- Clinical indication for diagnostic coronary angiography
- Willing and able to provide informed consent for study participation
You will not qualify if you...
- Presence of obstructive coronary artery disease (stenosis ≥ 70% or FFR ≤ 0.80 in main vessels)
- History of myocardial infarction, coronary stent placement, or coronary artery bypass surgery
- Diagnosis of type II diabetes
- Body mass index (BMI) of 35 kg/m2 or higher
- Stage IV or V chronic kidney disease (eGFR ≤ 30 ml/min)
- Allergy or contraindication to iodinated contrast, gadolinium, or adenosine
- Chronic resting oxygen saturation of 85% or less
- Pregnancy or suspected pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to 1 day for diagnostic procedures
Participants undergo multimodality diagnostic tests including blood tests, echocardiography, coronary angiography, coronary microvascular function assessment, and hyperinsulinemic-euglycemic clamp test to evaluate coronary microvascular dysfunction and insulin resistance.
1 to 2 visits depending on testing schedule
Duration - 12 months
Participants receive clinical follow-up through outpatient visits or telephone contacts to assess metabolic and cardiac function over time.
Follow-up visits at 6 and 12 months with blood tests and echocardiography at 12 months
Trial Site Locations
Total: 1 location
1
Azienda Ospedaliera Universitaria di Verona
Verona, VR, Italy, 37126
Actively Recruiting
Research Team
N
Natascia Antonioli
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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