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

University Hospital Center (CHU)

Status: Completed

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

Study type: Observational

Funder types: Other

Identifiers

NCT07204847

2024-12-185

Details and patient eligibility

About

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.

Full 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.

Enrollment: 407 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

407 participants in 2 patient groups

Early intervention

Description:

Invasive coronary angiography within 24 hours after diagnosis

Delayed intervention

Description:

Invasive coronary angiography more than 24 hours after diagnosis