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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06446895
Other study ID # IMACORN-INFLI
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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 donĀ“t sign informed consent

Study Design


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.
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