Invasive vs Conservative Strategies in Non-ST-elevation Acute Coronary Syndrome and Comorbidities

Study Overview
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Brief Summary
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The guidelines of clinical practice, based on the randomized studies, recommend an invasive strategy in non-ST elevation acute coronary syndrome (NSTEACS). However, patients with comorbidities are excluded from the randomized studies and the observational registries showthat patients with comoribidities undergo fewer cardiac catheterizations. The aim is to investigate the benefit of the invasive strategy in patients with NSTEACS and comorbidities. Patients hospitalized with NSTEACS, older than 70 years and with significant comorbidities, will be included. The latter will be defined as at least 2 of the following: peripheral artery disease, cerebral vascular disease, dementia, chronic pulmonary disease, chronic renal failure and anemia. The included patients will be randomized to an invasive (routine coronary angiogram) or conservative (coronary angiogram only if recurrent or inducible ischemia) strategy. All patients will receive medical treatment according to current recommendations. The main outcome will be death, reinfarction or readmissions by heart cause at one-year follow-up. The hypothesis is that an invasive strategy will improve prognosis in patients with NSTEACS and comorbidities.

Official Title
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Randomized Comparison Between Invasive and Conservative Strategies in Patients With Non-ST-segment Elevation Acute Coronary Syndrome and Comorbidities

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Procedure: Coronary angiogram


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age =>70 years old Angina chest pain Troponin elevation At least 2 of the following comorbidities: A) Documented peripheral artery disease. B)Renal filaure (GFR <45 ml/min/m2). C) Neurological disease with permanent deficit. D) Dementia (Pfeiffer test). E) Chronic pulmonary disease (Gold>2 or ambulatory oxigen therapy). Anemia (Hb =<11 g/dl) Exclusion Criteria: Dynamic ST changes (=>1 mm) in the initial ECG Prior known non-revascularizable coronay disease Concomitant heart disease different to coronary disease Life expentancy < 1 year

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Conservative<br>Coronary angiogram only if recurrent ischemia or peristent heart failure or inducible ischemia in predischarge stress test if perfomed | |
| Active Comparator: Invasive<br>Routine coronary angiogram | Procedure: Coronary angiogram<br>* Routine coronary angiogram and revascularization if indicated<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality, reinfarction or reasmission by cardiac cause |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days alive out of the hospital |  | 1 year | 
| Bleeding |  | In-hospital (average= 1 week) | 
| Renal failure |  | In-hospital (average= 1 week) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-ST-elevation acute myocardial infarction, Comorbidities