New Approaches to INOCA

NCT ID: NCT05740345

Last Updated: 2023-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-15

Study Completion Date

2021-01-15

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.

Conditions

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New Approaches in INOCA

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Hyperglycemia/Normoglycemia

No interventions assigned to this group

Treated/No treated

Metformin

Intervention Type DRUG

Metformin

Interventions

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Metformin

Metformin

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pasquale Mone

OTHER

Sponsor Role lead

Responsible Party

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Pasquale Mone

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Other Identifiers

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Campania Nord 2

Identifier Type: -

Identifier Source: org_study_id

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