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NCT Number: NCT07204847

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

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.

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Key information

About this study

Primary Objective: To describe the predictive values (sensitivity and specificity) of the timing of coronary angiography after the diagnosis of NSTEMI.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Presence of chest pain with or without ECG changes
  • 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

  • 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

Treatment and study plan

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

    Time frame: From enrollment to 6 months

    Sensibility and specificity, positive and negative predictive values

Secondary outcomes

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

    Time frame: From enrollment to 6 months

    Using a receiver operating characteristic (ROC) curve

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

    Time frame: From enrollment to 6 months

    Composite of overall mortality, recurrent myocardial infarction, stroke and hospitalization for heart failure

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

    Time frame: From enrollment to 1 month

    Composite criteria of overall mortality, recurrent myocardial infarction, stroke and hospitalization for heart failure

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

    Time frame: From enrollment to 6 months

    Overall mortality, recurrent myocardial infarction, stroke and hospitalization for heart failure

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

    Time frame: At enrollment

    Within 24 hours

  6. Comparison of major bleeding at 6 months

    Time frame: From enrollment to 6 months

  7. Length of in-patient stay

    Time frame: 6 months

    Duration in days between the date of admission at the participating hospital and the date of discharge during the index hospitalization

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • University Hospital, Nīmes

Registry information

Official study title

Prognostic Impact of Guideline-recommended Timing for Invasive Strategy in NSTEMI: a Prospective Real-world Study

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 2, 2025
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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