Incidence, Clinical Characteristics and Outcomes of Unstable Angina in the contempoRary Area. (ICAR)

April 30, 2024 updated by: University Hospital, Montpellier

Incidence, Clinical Characteristics and Outcomes of Unstable Angina in the contempoRary Area. ICAR Observational Study

The study aims to evaluate clinical characteristics and prognostic of a contemporary population of patients with UA defined using T hs-cTn measurements The study includes all patients admitted in 2 French university centers with the confirmed diagnostic of UA defined with clinical ischemic symptoms and T hs-cTn concentrations < 99 percentile (undetectable: <5ng/l or non-elevated: <14ng/l), or ≥ 99 percentile but mildly elevated (14-50ng/l) .The primary end-point included major events at 1-year follow-up (total mortality, new ACS, hospitalization for cardiac causes).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

210

Contacts and Locations

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

Study Locations

  • France
      • Montpellier, France, 34295
        • University Hospital of Montpellier

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 with unstable angina proven by coronary angiography admitted to Montpellier and Nîmes hospitals between November 2021 and January 2023.

Description

Inclusion criteria:

  • Patients with ischemic symptoms at rest or minor exercise without evidence of acute myocardial necrosis.
  • Ischemic symptoms may include typical or atypical angina pectoris and worsening/deterioration of previously stable angina with or without electrical signs of ischemia on the electrocardiogram.
  • hs-cTn concentrations are in the normal range or may be slightly elevated > 99th percentile (i.e. low troponin T elevation ≤ 50 * Elecsys Roche) but with absence of significant kinetics according to criteria defined in the literature (<20%).

  • One of the following angiographic criteria is required:

    • Coronary angiography revealing a stenosis with a diameter of at least 70%.
    • Stenosis of at least 50% diameter in the left common trunk.
    • FFR (Fractional Flow Reserve) documenting ischemia per coronary angiography of a coronary lesion in the case of intermediate stenosis (50-70%).
    • If there are no significant lesions, a spasm must be proven by an ergonovine test.

Exclusion criteria:

  • NSTEMI and STEMI.
  • Coronaries normal or without significant lesions unless proven spasm.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients with hospitalisation for unstable angina
Time Frame: One year after hospitalisation for of unstable Angina
One year after hospitalisation for of unstable Angina

Collaborators and Investigators

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

Sponsor

University Hospital, Montpellier

Investigators

  • Study Director: Florence Leclercq, PUPH, Montpellier University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

November 27, 2022

Primary Completion (Actual)

January 27, 2024

Study Completion (Actual)

April 15, 2024

Study Registration Dates

First Submitted

April 18, 2024

First Submitted That Met QC Criteria

April 18, 2024

First Posted (Actual)

April 22, 2024

Study Record Updates

Last Update Posted (Actual)

May 2, 2024

Last Update Submitted That Met QC Criteria

April 30, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-01-023

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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