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

Unstable Angina Clinical Trial

— ICAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06378333
• Other study ID #: 2024-01-023
• Status: Completed
• Start date: November 27, 2022
• Est. completion date: April 15, 2024

Study information

• Verified date: April 2024
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: April 15, 2024
• Est. primary completion date: January 27, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Unstable
• Unstable Angina

Intervention

Procedure:
• patients who underwent coronary angiography
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.

Locations

Country	Name	City	State
France	University Hospital of Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with hospitalisation for unstable angina		One year after hospitalisation for of unstable Angina