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

Phase 4

Completed

• Conditions: Acute Coronary Syndrome
• Interventions: Procedure: Coronary angiogram

• Registration Number: NCT01645943
• Lead Sponsor: University of Valencia

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-07-13
• Study First Submitted QC: 2012-07-17
• Study First Posted: 2012-07-20
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-24
• Last Update Posted: 2016-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Invasive	Coronary angiogram	Routine coronary angiogram

Primary Outcome Measures

Name	Time	Method
All cause mortality, reinfarction or reasmission by cardiac cause	1 year

Secondary Outcome Measures

Name	Time	Method
Days alive out of the hospital	1 year
Renal failure	In-hospital (average= 1 week)
Bleeding	In-hospital (average= 1 week)

Trial Locations

Locations (6)

Hospital Pujol i Trias; 🇪🇸 Badalona, Barcelona, Spain

Hospital Virgen del Rosell; 🇪🇸 Cartagena, Murcia, Spain

Hospital Valle Hebrón; 🇪🇸 Barcelona, Spain

Hopsital Clinic; 🇪🇸 Barcelona, Spain

Hospital Virgen Arrixaca; 🇪🇸 Murcia, Spain

Hospital Clínico Universitario; 🇪🇸 Valencia, Spain