Prognostic Impact of Guideline-recommended Timing for Invasive Strategy in NSTEMI
NCT ID: NCT07204847
Last Updated: 2025-10-02
Study Results
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Basic Information
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COMPLETED
407 participants
OBSERVATIONAL
2023-11-01
2025-06-20
Brief Summary
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Detailed Description
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Secondary Objective: To evaluate an optimal threshold for the timing of coronary angiography that predicts poor prognosis at 6 months (Composite MACCE criterion including all-cause death, recurrent myocardial infarction, hospitalization for cardiac reasons, stroke) (MACCE = Major Adverse Cardiac and Cerebral Events, stroke = cerebrovascular accident).
Comparisons:
Comparison of severe events at 6 months (Composite MACCE criterion including all-cause death, recurrent myocardial infarction, hospitalization for cardiac reasons, stroke) based on the timing of coronary angiography after the diagnosis of NSTEMI according to recommendations (within 24 hours vs. more than 24 hours).
Comparison of severe events at 6 months (all-cause death, recurrent myocardial infarction, hospitalization for cardiac reasons, stroke, considered separately) based on the timing of coronary angiography after the diagnosis of NSTEMI according to recommendations (within 24 hours vs. more than 24 hours).
Comparison of severe events at 1 month (Composite MACCE criterion including all-cause death, recurrent myocardial infarction, hospitalization for cardiac reasons, stroke) based on the timing of coronary angiography after the diagnosis of NSTEMI according to recommendations (within 24 hours vs. more than 24 hours).
Comparison of the occurrence of severe events (Composite MACCE criterion including all-cause death, recurrent myocardial infarction, hospitalization for cardiac reasons, stroke, treated as survival data) based on the timing of coronary angiography after the diagnosis of NSTEMI according to recommendations (within 24 hours vs. more than 24 hours).
Additional Descriptions:
Description of the prevalence of patients for whom the recommended timing of coronary angiography is followed.
Comparison of the characteristics of patients who underwent coronary angiography within 24 hours versus those who did not (age, LVEF (left ventricular ejection fraction), troponin level, creatinine, NYHA class (New York Heart Association heart failure classification)).
Comparison of the length of hospitalization based on the timing of coronary angiography.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Early intervention
Invasive coronary angiography within 24 hours after diagnosis
No interventions assigned to this group
Delayed intervention
Invasive coronary angiography more than 24 hours after diagnosis
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Elevation of troponin level \> 90th percentile or a significant increase between two dosages
* Significant or non-significant coronary lesion confirming the diagnosis of coronary artery disease on coronary angiography (coronary angiography mandatory before inclusion to confirm NSTEMI)
Exclusion Criteria
* Very high-risk NSTEMI (hemodynamic instability, cardiogenic shock, recurrent/refractory chest pain despite optimal medical treatment, life-threatening arrhythmia, mechanical complication, heart failure clearly related to NSTEMI, ST depression \> 1mm/6 leads with ST elevation in aVR and/or V1) for which urgent coronary angiography is mandatory
* Unstable angina (acute coronary syndrome without troponin elevation)
* Troponin elevation without chest pain or symptoms suggestive of NSTEMI
* Recovered cardiac arrest
* Contraindication to coronary revascularization or coronary angiography
* Other diagnoses considered after coronary angiography (e.g., myocarditis, Takotsubo syndrome)
* Age \< 18 years
18 Years
ALL
No
Sponsors
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University Hospital, Nīmes
UNKNOWN
University Hospital, Montpellier
OTHER
Responsible Party
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Locations
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CHU de Montpellier
Montpellier, , France
Countries
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References
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Fox KA, Clayton TC, Damman P, Pocock SJ, de Winter RJ, Tijssen JG, Lagerqvist B, Wallentin L; FIR Collaboration. Long-term outcome of a routine versus selective invasive strategy in patients with non-ST-segment elevation acute coronary syndrome a meta-analysis of individual patient data. J Am Coll Cardiol. 2010 Jun 1;55(22):2435-45. doi: 10.1016/j.jacc.2010.03.007. Epub 2010 Mar 30.
Mehta SR, Granger CB, Boden WE, Steg PG, Bassand JP, Faxon DP, Afzal R, Chrolavicius S, Jolly SS, Widimsky P, Avezum A, Rupprecht HJ, Zhu J, Col J, Natarajan MK, Horsman C, Fox KA, Yusuf S; TIMACS Investigators. Early versus delayed invasive intervention in acute coronary syndromes. N Engl J Med. 2009 May 21;360(21):2165-75. doi: 10.1056/NEJMoa0807986.
Kofoed KF, Kelbaek H, Hansen PR, Torp-Pedersen C, Hofsten D, Klovgaard L, Holmvang L, Helqvist S, Jorgensen E, Galatius S, Pedersen F, Bang L, Saunamaki K, Clemmensen P, Linde JJ, Heitmann M, Wendelboe Nielsen O, Raymond IE, Kristiansen OP, Svendsen IH, Bech J, Dominguez Vall-Lamora MH, Kragelund C, Hansen TF, Dahlgaard Hove J, Jorgensen T, Fornitz GG, Steffensen R, Jurlander B, Abdulla J, Lyngbaek S, Elming H, Therkelsen SK, Abildgaard U, Jensen JS, Gislason G, Kober LV, Engstrom T. Early Versus Standard Care Invasive Examination and Treatment of Patients With Non-ST-Segment Elevation Acute Coronary Syndrome. Circulation. 2018 Dec 11;138(24):2741-2750. doi: 10.1161/CIRCULATIONAHA.118.037152.
Kite TA, Kurmani SA, Bountziouka V, Cooper NJ, Lock ST, Gale CP, Flather M, Curzen N, Banning AP, McCann GP, Ladwiniec A. Timing of invasive strategy in non-ST-elevation acute coronary syndrome: a meta-analysis of randomized controlled trials. Eur Heart J. 2022 Sep 1;43(33):3148-3161. doi: 10.1093/eurheartj/ehac213.
Other Identifiers
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2024-12-185
Identifier Type: -
Identifier Source: org_study_id
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