Prognostic Impact of Guideline-recommended Timing for Invasive Strategy in NSTEMI

NCT07204847 | Completed

• 1 other identifier: 2024-12-185
• Study Type: observational
• Target: 407
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this multicentric observational study is to evaluate the prognostic influence of adherence or non-adherence to the recommended coronary angiography timeframe (within 24 hours) and the six-month prognosis of the patients.

Conditions

NSTEMI; NSTE-ACS (NSTEMI and UA); NSTEMI - Non-ST-Segment Elevation Myocardial Infarction

Keywords

NSTEMI; NSTE-ACS; Invasive strategy timing; Early or delayed intervention

Outcome Measures

Primary Outcomes (1)

• Describe the predictive value of the timing of invasive coronary angiography on a composite criteria of overall mortality, recurrent myocardial infarction, stroke, hospitalization for heart failure at 6 months

  Sensibility and specificity, positive and negative predictive values

  From enrollment to 6 months

Secondary Outcomes (7)

• Evaluation of the optimal timing of invasive coronary angiography predicting a negative outcome at 6 months

  From enrollment to 6 months

• Comparison of the composite criteria of an invasive coronary angiography within 24h and after 24h at 6 months

  From enrollment to 6 months

• Comparison of the composite criteria of an invasive coronary angiography within 24h and after 24h at 1 month

  From enrollment to 1 month

• Comparison of each element of the composite criteria individually at 6 months of an invasive coronary angiography within 24h and after 24h

  From enrollment to 6 months

• Describe the prevalence of patients receiving an invasive in respect to the timing of the guidelines

  At enrollment

Study Arms (2)

Early intervention

Invasive coronary angiography within 24 hours after diagnosis

Delayed intervention

Invasive coronary angiography more than 24 hours after diagnosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The included patients are those diagnosed with NSTEMI who have undergone coronary angiography as recommended, with no changes to the subsequent patient follow-up

You may qualify if:

• Presence of chest pain with or without ECG changes
• Elevation of troponin level \> 90th percentile or a significant increase between two dosages

You may not qualify if:

• STEMI (ST-segment elevation myocardial infarction) or equivalent (defined as chest pain with ECG changes and troponin elevation \> 5 times the normal with an occluded artery (TIMI 0, 1, or 2) during initial coronary angiography)
• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• University Hospital, Nīmes: collaborator

Study Sites (1)

CHU de Montpellier

Montpellier, 34000, France

Location

Related Publications (4)

• 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.

  PMID: 20359842 BACKGROUND

• 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.

  PMID: 19458363 BACKGROUND

• 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.

  PMID: 30565996 BACKGROUND

• 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.

  PMID: 35514079 BACKGROUND

MeSH Terms

Conditions

Non-ST Elevated Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: October 2, 2025
• Study Start: November 1, 2023
• Primary Completion: May 1, 2025
• Study Completion: June 20, 2025
• Last Updated: October 2, 2025

Record last verified: 2025-09

Locations

FR (1)