NCT06446895

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).

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2024

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 6, 2024

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

June 6, 2024

Status Verified

May 1, 2024

Enrollment Period

3.6 years

First QC Date

May 27, 2024

Last Update Submit

May 31, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

  • 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.

  • 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.

Study Arms (2)

MICAD

Patients with Myocardial Infarction and Obstructive Coronary Arteries

Diagnostic Test: Coronariography

MINOCA

Patients with Myocardial Infarction and Non-obstructive Coronary Arteries

Diagnostic Test: Coronariography

Interventions

CoronariographyDIAGNOSTIC_TEST

Patients were classified as MICAD or MINOCA by the presence or absence of an epicardial vessel with ≥50% stenosis after performing a coronariography.

MICADMINOCA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Patients who don´t sign informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario de Getafe

Getafe, Madrid, 28905, Spain

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, plasma, urine

MeSH Terms

Conditions

Myocardial InfarctionMINOCAInflammation

Interventions

Coronary Angiography

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisAngiographyRadiographyDiagnostic Techniques, CardiovascularHeart Function Tests

Central Study Contacts

MARIA JESUS ESPINOSA, MD

CONTACT

JOAQUIN ALONSO, PHD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cardiologist

Study Record Dates

First Submitted

May 27, 2024

First Posted

June 6, 2024

Study Start

October 1, 2020

Primary Completion

May 22, 2024

Study Completion

May 31, 2025

Last Updated

June 6, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations