New Approaches to INOCA

Management of Hyperglycemia in INOCA Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05740345

Enrollment

3000

Registered

2023-02-23

Start date

2016-01-15

Completion date

2021-01-15

Last updated

2023-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

New Approaches in INOCA

Keywords

INOCA, Hyperglycemia, Metformin, Endothelial Dysfunction, PCI

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.

Interventions

DRUGMetformin

Metformin

Study design

Observational model

OTHER

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026