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

May 31, 2024 updated by: maria jesus espinosa pascual, Hospital Universitario Getafe
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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients older than 18 years old admitted to our hospital with Myocardial Infarction and undergo a coronariography.

Description

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 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
MICAD
Patients with Myocardial Infarction and Obstructive Coronary Arteries
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.
MINOCA
Patients with Myocardial Infarction and Non-obstructive Coronary Arteries
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Hospital Universitario Getafe

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)

October 1, 2020

Primary Completion (Actual)

May 22, 2024

Study Completion (Estimated)

May 31, 2025

Study Registration Dates

First Submitted

May 27, 2024

First Submitted That Met QC Criteria

May 31, 2024

First Posted (Actual)

June 6, 2024

Study Record Updates

Last Update Posted (Actual)

June 6, 2024

Last Update Submitted That Met QC Criteria

May 31, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMACORN-INFLI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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