Biomarkers of Inflammation and Endothelial Dysfunction in Patients With Myocardial Infarction With Non-obstructive Coronary Arteries

Recruiting

• Conditions: MINOCA; Endothelial Dysfunction; Myocardial Infarction; Inflammation; Biomarkers
• Interventions: Diagnostic Test: Coronariography

• Registration Number: NCT06446895
• Lead Sponsor: Hospital Universitario Getafe

Brief Summary

Around 10% of patients with myocardial infarction (MI) present with nonobstructive coronary arteries (MINOCA) which pathophysiology is often uncertain. The aim of the study is to evaluate inflammation and endothelial dysfunction biomarkers in MINOCA patients during both acute and stable phases, comparing them with those with MI and obstructive coronary arteries (MICAD).

Detailed Description

Prospective observational study in patients with Myocardial Infarction (MI) divided into two groups: MI with obstructive coronary arteries (MICAD) and MI with non-obstructive coronary arteries (MINOCA). Levels of interleukin-6, tumor necrosis factor-alpha, high-sensitivity C- reactive protein, and asymmetric dimethylarginine will be determined at three time points: within the 24 hours from the onset of pain, discharge, and two months after MI. The association of biomarkers, normalized by peak troponin value, with the risk of MINOCA will be evaluated using logistic regression.

Study Timeline

• Study Start: 2020-10-01
• Status Verified: 2024-05
• Primary Completion: 2024-05-22
• Study First Submitted: 2024-05-27
• Study First Submitted QC: 2024-05-31
• Last Update Submitted: 2024-05-31
• Study First Posted: 2024-06-06
• Last Update Posted: 2024-06-06
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Patients admitted with Myocardial Infarction and undergo a coronariography
• Patients must sign informed consent.

Exclusion Criteria

• Patients who don´t sign informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MICAD	Coronariography	Patients with Myocardial Infarction and Obstructive Coronary Arteries
MINOCA	Coronariography	Patients with Myocardial Infarction and Non-obstructive Coronary Arteries

Primary Outcome Measures

Name	Time	Method
Levels of endhotelial disfunction biomarkers	At three time points: within the 24 hours from the onset of pain, on the 5th day of admission, and two months after MI.	Levels of asymmetric dimethylarginine will be determined
Levels of high-sensitivity C-reactive protein (mg/L)	t three time points: within the 24 hours from the onset of pain, on the 5th day of admission, and two months after MI.	Levels of high-sensitivity C-reactive protein (mg/L) will be determined.
Levels of interleukin-6 (pg/ml) and tumor necrosis factor-alpha (pg/ml)	At three time points: within the 24 hours from the onset of pain, on the 5th day of admission, and two months after MI.	Levels of interleukin-6 (pg/ml) and tumor necrosis factor-alpha (pg/ml) will be determined.

Trial Locations

Locations (1)

Hospital Universitario de Getafe; 🇪🇸 Getafe, Madrid, Spain