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

University of Valencia

Status and phase: Completed; Phase 4

Conditions: Acute Coronary Syndrome

Treatments: Procedure: Coronary angiogram

Study type: Interventional

Funder types: Other

Identifiers

NCT01645943

11/ 01595

Details and patient eligibility

About

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.

Enrollment: 109 patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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109 participants in 2 patient groups

Conservative

No Intervention group

Description:

Coronary angiogram only if recurrent ischemia or peristent heart failure or inducible ischemia in predischarge stress test if perfomed

Invasive

Active Comparator group

Description:

Routine coronary angiogram

Treatment:

Procedure: Coronary angiogram