NCT06378333Completed
Incidence, Clinical Characteristics and Outcomes of Unstable Angina in the contempoRary Area.
Incidence, Clinical Characteristics and Outcomes of Unstable Angina in the contempoRary Area. ICAR Observational Study
Source: ClinicalTrials.gov · Last updated 2 May 2024
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 210 (actual)
- First submitted
- 18 Apr 2024
- Start date
- Nov 2022
- Primary completion date
- Jan 2024
- Lead sponsor
- University Hospital, Montpellier
- Diseases
- Coronary artery disease
- NCT number
- NCT06378333
What you commit to
- Study type: Observational
- Participants enrolled: 210
- From Nov 2022 to the primary completion date, Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- NSTEMI and STEMI.
- Coronaries normal or without significant lesions unless proven spasm.
Who the study is looking for
- 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.
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital of Montpellier Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.