Clinical trial NCT06378333: Incidence, Clinical Characteristics and Outcomes of Unstable Angina in the contempoRary Area.
Official title: Incidence, Clinical Characteristics and Outcomes of Unstable Angina in the contempoRary Area. ICAR Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Unstable Angina
Keywords: cardiology
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2024-04-22
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief summary: 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Number of patients with hospitalisation for unstable angina
timeFrame: One year after hospitalisation for of unstable Angina
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University Hospital of Montpellier
Study officials:
affiliation: Montpellier University Hospital
name: Florence Leclercq, PUPH
role: STUDY_DIRECTOR
References:
citation: Hamm CW, Braunwald E. A classification of unstable angina revisited. Circulation. 2000 Jul 4;102(1):118-22. doi: 10.1161/01.cir.102.1.118.
citation: Puelacher C, Gugala M, Adamson PD, Shah A, Chapman AR, Anand A, Sabti Z, Boeddinghaus J, Nestelberger T, Twerenbold R, Wildi K, Badertscher P, Rubini Gimenez M, Shrestha S, Sazgary L, Mueller D, Schumacher L, Kozhuharov N, Flores D, du Fay de Lavallaz J, Miro O, Martin-Sanchez FJ, Morawiec B, Fahrni G, Osswald S, Reichlin T, Mills NL, Mueller C. Incidence and outcomes of unstable angina compared with non-ST-elevation myocardial infarction. Heart. 2019 Sep;105(18):1423-1431. doi: 10.1136/heartjnl-2018-314305. Epub 2019 Apr 24.
citation: Kristensen AMD, Pareek M, Kragholm KH, Sehested TSG, Olsen MH, Prescott EB. Unstable Angina as a Component of Primary Composite Endpoints in Clinical Cardiovascular Trials: Pros and Cons. Cardiology. 2022;147(3):235-247. doi: 10.1159/000524948. Epub 2022 May 10.
citation: Eggers KM, Jernberg T, Lindahl B. Unstable Angina in the Era of Cardiac Troponin Assays with Improved Sensitivity-A Clinical Dilemma. Am J Med. 2017 Dec;130(12):1423-1430.e5. doi: 10.1016/j.amjmed.2017.05.037. Epub 2017 Jun 21.
citation: Vafaie M, Slagman A, Mockel M, Hamm C, Huber K, Muller C, Vollert JO, Blankenberg S, Katus HA, Liebetrau C, Giannitsis E, Searle J. Prognostic Value of Undetectable hs Troponin T in Suspected Acute Coronary Syndrome. Am J Med. 2016 Mar;129(3):274-82.e2. doi: 10.1016/j.amjmed.2015.10.016. Epub 2015 Oct 30.
citation: Olivier CB, Sundaram V, Bhatt DL, Leonardi S, Lopes RD, Ding VY, Yang L, Stone GW, Steg PG, Gibson CM, Hamm CW, Price MJ, White HD, Desai M, Lynch DR Jr, Harrington RA, Mahaffey KW; CHAMPION PLATFORM and CHAMPION PCI Investigators. Definitions of peri-procedural myocardial infarction and the association with one-year mortality: Insights from CHAMPION trials. Int J Cardiol. 2018 Nov 1;270:96-101. doi: 10.1016/j.ijcard.2018.06.034. Epub 2018 Jun 8.