Management of Hyperglycemia in INOCA Patients
Overview
- Phase
- Not Applicable
- Intervention
- Metformin
- Conditions
- New Approaches in INOCA
- Sponsor
- Pasquale Mone
- Enrollment
- 3000
- Primary Endpoint
- Risk of Re-Hospitalization
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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
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.
Investigators
Pasquale Mone
Principal Investigator
University of Campania "Luigi Vanvitelli"
Eligibility Criteria
Inclusion Criteria
- •age ≥18 years;
- •diagnosis of INOCA;
- •availability to participate in the study
Exclusion Criteria
- •atrial fibrillation or left bundle branch block;
- •previous acute coronary syndrome (ACS) or cardiac revascularization; -pregnancy;
- •severe heart valve disease
Arms & Interventions
Treated/No treated
Intervention: Metformin
Outcomes
Primary Outcomes
Risk of Re-Hospitalization
Time Frame: 2016-2021
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.
Secondary Outcomes
- MACE(2016-2021)