New Approaches to INOCA

February 21, 2023 updated by: Pasquale Mone

Management of Hyperglycemia in INOCA Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

3000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

INOCA with Hyperglycemia

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hyperglycemia/Normoglycemia
Treated/No treated
Drug: Metformin
Metformin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2016-2021

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACE
Time Frame: 2016-2021

Major adverse cardiovascular event (MACE):

Acute myocardial infarction or acute coronary syndrome, stroke, cardiovascular death, all-cause death
2016-2021

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pasquale Mone

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2016

Primary Completion (Actual)

January 15, 2019

Study Completion (Actual)

January 15, 2021

Study Registration Dates

First Submitted

January 30, 2023

First Submitted That Met QC Criteria

February 21, 2023

First Posted (Estimate)

February 23, 2023

Study Record Updates

Last Update Posted (Estimate)

February 23, 2023

Last Update Submitted That Met QC Criteria

February 21, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Campania Nord 2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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