New Approaches to INOCA

Completed

• Conditions: New Approaches in INOCA
• Interventions: Drug: Metformin

• Registration Number: NCT05740345
• Lead Sponsor: Pasquale Mone

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.

Study Timeline

• Study Start: 2016-01-15
• Primary Completion: 2019-01-15
• Study Completion: 2021-01-15
• Study First Submitted: 2023-01-30
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-21
• Last Update Submitted: 2023-02-21
• Study First Posted: 2023-02-23
• Last Update Posted: 2023-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treated/No treated	Metformin	-

Primary Outcome Measures

Name	Time	Method
Risk of Re-Hospitalization	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 Outcome Measures

Name	Time	Method
MACE	2016-2021	Major adverse cardiovascular event (MACE): Acute myocardial infarction or acute coronary syndrome, stroke, cardiovascular death, all-cause death