New Approaches to INOCA

Study Overview
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Brief Summary
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Ischemia with non-obstructive coronary arteries (INOCA) is common in patients with angina. INOCA has been associated with an increased risk of death, myocardial infarction, and stroke, particularly in symptomatic subjects. Previous investigations have evidenced the key role of poor glycemic control and diabetes in coronary microvascular dysfunction. Metformin is an old oral antidiabetic drug which is currently used to achieve glycemic control.

Detailed Description
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Ischemia with non-obstructive coronary arteries (INOCA) is common in patients with angina. INOCA has been associated with an increased risk of death, myocardial infarction, and stroke, particularly in symptomatic subjects. Coronary microvascular dysfunction, triggering structural remodeling and vasomotor disorders of coronary arterioles, is currently one of the leading hypotheses to explain INOCA pathophysiology. Previous investigations have evidenced the key role of poor glycemic control and diabetes in coronary microvascular dysfunction. Metformin is an old oral antidiabetic drug which is currently used to achieve glycemic control. Also, previous reports evidenced that metformin improves endothelial dysfunction. Nowadays, it is used in prediabetic patients too. In this scenario, we evaluated the role of metformin in reducing the risk of re-hospitalization in INOCA.

Official Title
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Management of Hyperglycemia in INOCA Patients

Conditions
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New Approaches in INOCA

Intervention / Treatment
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* Drug: Metformin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age ≥18 years; diagnosis of INOCA; availability to participate in the study Exclusion Criteria: cancer; atrial fibrillation or left bundle branch block; previous acute coronary syndrome (ACS) or cardiac revascularization; -pregnancy; severe heart valve disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hyperglycemia/Normoglycemia<br> | |
| Treated/No treated<br> | Drug: Metformin<br>* Metformin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk of Re-Hospitalization | Risk of Re-Hospitalization. The primary outcome measure will be the risk of re-hospitalization; to assess this outcome, we will assess the actual number of re-hospitalization events for each patients. | 2016-2021 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE | Major adverse cardiovascular event (MACE): Acute myocardial infarction or acute coronary syndrome, stroke, cardiovascular death, all-cause death | 2016-2021 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PCI, INOCA, Hyperglycemia, Metformin, Endothelial Dysfunction