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

Myocardial Infarction Clinical Trial

— IMACORN-INFLI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06446895
• Other study ID #: IMACORN-INFLI
• Status: Recruiting
• Start date: October 1, 2020
• Est. completion date: May 31, 2025

Study information

• Verified date: May 2024
• Source: Hospital Universitario Getafe
• Contact: MARIA JESUS ESPINOSA, MD
• Phone: 636581691
• Email: mariajesusespinosapascual[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: May 31, 2025
• Est. primary completion date: May 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Biomarkers
• Endothelial Dysfunction
• Infarction
• Inflammation
• Myocardial Infarction

Intervention

Diagnostic Test:
• Coronariography
Patients were classified as MICAD or MINOCA by the presence or absence of an epicardial vessel with =50% stenosis after performing a coronariography.

Locations

Country	Name	City	State
Spain	Hospital Universitario de Getafe	Getafe	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Getafe

Country where clinical trial is conducted

Spain, 

Outcome

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