Status:

COMPLETED

Multiomics and Imaging-based Assessment of Vulnerable Coronary Plaques in Acute Coronary Syndromes

Lead Sponsor:

Cardio Med Medical Center

Conditions:

Coronary Stenosis

Acute Coronary Syndrome

Eligibility:

All Genders

18+ years

Brief Summary

The aim of Multiplaque clinical study is to assess the vulnerability degree of the atheromatous plaques, before and after a myocardial infarction (MI), based on multiomics analysis, associated with in...

Detailed Description

This is a prospective cohort monocentric study. The primary objective of this study is to research the vulnerability degree of ateromatous plaques before and after a myocardial infarction, based on m...

Eligibility Criteria

Inclusion

  • Substudy 1:
  • Patients aged at least 18 years
  • Patients who have signed the informed consent
  • Unstable angina type acute coronary syndrome with maximum 48h before presentation, defined as the presence of typical angina pain, with duration of more than 5 minute, accompanied by ECG changes.
  • Substudy 2:
  • Patients aged at least 18 years
  • Patients who have signed the informed consent
  • Acute myocardial infarction (STEMI or NSTEMI) defined as typical changes on the ECG (ST elevation of minimum 1 mm in at least 2 consecutive leads - STEMI; ST-T changes for NSTEMI) accompanied by increased levels of cardiac troponin I or T, or CK-MB of more than 2x the normal reference value of the laboratory.

Exclusion

  • (for both substudies)
  • Known sensibility for the contrast agents
  • Women at reproductive age who does not use contraceptive methods
  • Pregnant women
  • Any malignancy within the last 5 years
  • Acute or chronic renal failure
  • Any disease or comorbidity that reduces the life expectancy under 2 years
  • Non-compliant patients who, in the opinion of the investigators, will not undergo the follow-up process

Key Trial Info

Start Date :

April 1 2018

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

January 31 2021

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT03391908

Start Date

April 1 2018

End Date

January 31 2021

Last Update

August 2 2022

Active Locations (1)

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1

Cardio Med SRL

Târgu Mureş, Mureș County, Romania, 540136