Coronary artery bypass graft surgery in patients with asymptomatic carotid stenosis

Phase 4

• Conditions: I25; I65.2; Chronic ischaemic heart disease; Occlusion and stenosis of carotid artery

• Registration Number: DRKS00000521
• Lead Sponsor: niversitätsklinikum Essen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08-20
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: All
• Target Recruitment: 129

Inclusion Criteria

Key inclusion criteria:
1. Identification of a =80% stenosis (ECST criteria) of the extracranial carotid artery in a patient scheduled for coronary artery bypass graft (CABG) surgery with the stenosis being asymptomatic for the past 180 days
2. Carotid stenosis treatable with CEA
3. Written informed consent
4. Male or female patients of age =18 years

Exclusion Criteria

Key exclusion criteria:
1. Stenosis related neurological symptoms within the previous 180 days
2. Non-atherosclerotic origin of stenosis
3. NSTEMI within the past 48 hours, STEMI within the past 7 days or hemodynamically unstable patients
4. Modified Rankin Scale score >3 or severe aphasia

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary efficacy endpoint is the event rate of nonfatal strokes or deaths from any cause (whatever occurs first) within 30 days after the intervention (either isolated CABG or synchronous CABG + CEA).

Secondary Outcome Measures

Name	Time	Method
Secondary efficacy endpoints are single components of the primary endpoint, myocardial infarction, technical failures, duration of ventilatory support, change of cognitive performance on the Demtec scale and observations at different time points.