NCT01645943

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 109 (actual)
• Sponsor: University of Valencia · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Coronary Syndrome

Interventions

Type	Name	Description
PROCEDURE	Coronary angiogram	Routine coronary angiogram and revascularization if indicated

Timeline

• Start date: 2012-01-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2012-07-20
• Last updated: 2016-10-26

Locations

6 sites across 1 country: Spain