NSTE-ACS (NSTEMI and UA), NSTEMI, NSTEMI - Non-ST-Segment Elevation Myocardial Infarction
Conditions
Keywords
NSTEMI, NSTE-ACS, Invasive strategy timing, Early or delayed intervention
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.
Detailed description
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.
Interventions
None listed
Sponsors
University Hospital, Nīmes
University Hospital, Montpellier
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | From enrollment to 6 months | Sensibility and specificity, positive and negative predictive values |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the optimal timing of invasive coronary angiography predicting a negative outcome at 6 months | From enrollment to 6 months | Using a receiver operating characteristic (ROC) curve |
| Comparison of the composite criteria of an invasive coronary angiography within 24h and after 24h at 6 months | From enrollment to 6 months | Composite of overall mortality, recurrent myocardial infarction, stroke and hospitalization for heart failure |
| Comparison of the composite criteria of an invasive coronary angiography within 24h and after 24h at 1 month | From enrollment to 1 month | Composite criteria of overall mortality, recurrent myocardial infarction, stroke and hospitalization for heart failure |
| Length of in-patient stay | 6 months | Duration in days between the date of admission at the participating hospital and the date of discharge during the index hospitalization |
| Describe the prevalence of patients receiving an invasive in respect to the timing of the guidelines | At enrollment | Within 24 hours |
| Comparison of major bleeding at 6 months | From enrollment to 6 months | — |
| 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 | Overall mortality, recurrent myocardial infarction, stroke and hospitalization for heart failure |
Countries
France
Outcome results
None listed