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

NCT ID: NCT06378333

Last Updated: 2024-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

210 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-27

Study Completion Date

2024-04-15

Brief Summary

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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).

Detailed Description

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Conditions

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Unstable Angina

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Florence Leclercq, PUPH

Role: STUDY_DIRECTOR

Montpellier University Hospital

Locations

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University Hospital of Montpellier

Montpellier, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 31018955 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35537418 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28647406 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26524709 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29937301 (View on PubMed)

Jouen R, Meunier PA, Moulis L, Roubille F, Macia JC, Berdeu JM, Steinecker M, Robert P, Lattuca B, Cayla G, Leclercq F. Incidence and 1-Year Prognostic of Unstable Angina After High-Sensitivity Troponin Assessment. Catheter Cardiovasc Interv. 2025 May;105(6):1445-1452. doi: 10.1002/ccd.31473. Epub 2025 Mar 6.

Reference Type DERIVED
PMID: 40047210 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10880424 (View on PubMed)

Other Identifiers

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2024-01-023

Identifier Type: -

Identifier Source: org_study_id

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