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Completed

NCT Number: NCT05740345

New Approaches to INOCA

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.

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Key information

Conditions

New Approaches in INOCA Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

metformin

Drug

Metformin

Primary outcomes

  1. 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

  1. MACE

    Time frame: 2016-2021

    Major adverse cardiovascular event (MACE):

    Acute myocardial infarction or acute coronary syndrome, stroke, cardiovascular death, all-cause death

Sponsors and collaborators

Lead sponsor

Pasquale Mone

Other

Registry information

Official study title

Management of Hyperglycemia in INOCA Patients

Important dates

Study start
2016
Primary completion
2019
Study completion
2021
First posted
Feb 23, 2023
Registry last updated
Feb 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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