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

University Hospital Center (CHU) logo

University Hospital Center (CHU)

Status

Completed

Conditions

Unstable Angina

Treatments

Procedure: patients who underwent coronary angiography

Study type

Observational

Funder types

Other

Identifiers

NCT06378333
2024-01-023

Details and patient eligibility

About

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).

Enrollment

210 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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