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

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).

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Key information

Conditions

Unstable Angina Angina Pectoris Angina, Unstable Cardiovascular Diseases Chest Pain Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Montpellier

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

patients who underwent coronary angiography

Procedure

All patients included in the ICAR project (Montpellier - Nîmes) benefit from a consultation at one year (12+or - 2 months), as they are systematically reviewed in our department: data will therefore be collected in the patient's medical record. Clinical biological parameters and events during the hospital phase are also collected in the patient's computerized record. Normal patient management remains unchanged.

Primary outcomes

Number of patients with hospitalisation for unstable angina

Time frame: One year after hospitalisation for of unstable Angina

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: ICAR

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2024
First posted: Apr 22, 2024
Registry last updated: May 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed