Coronary Angiography Before Elective Carotid Endarterectomy in Patients With Asymptomatic Coronary Artery Disease

Carotid Stenosis Clinical Trial

— CACEA  

Official title:

Randomized Controlled Trial Analyzing the Role of Systematic Preoperative Coronary Angiography Before Elective Carotid Endarterectomy in Patients With Asymptomatic Coronary Artery Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02260453
• Other study ID #: University "La Sapienza" Rome
• Status: Completed
• Phase: Phase 3
• First received: October 6, 2014
• Last updated: October 8, 2014
• Start date: January 2005
• Est. completion date: June 2012

Study information

• Verified date: October 2014
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the potential benefit of systematic preoperative coronary angiography followed by selective coronary artery revascularization on the incidence of myocardial infarction (MI) in patients without a history of coronary artery disease (CAD) and undergoing carotid endarterectomy (CEA).

Description:

Patients candidates for CEA, with no history of CAD, a normal electrocardiogram (ECG), and a normal cardiac ultrasound were randomized in two groups. In group A (n = 216) all patients underwent coronary angiography before CEA +- coronary artery revascularization. In group B (n = 210) CEA was performed without coronary angiography.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 426
• Est. completion date: June 2012
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• indication for carotid endarterectomy

• no clinical sign or history of ischemic heart disease

• no electrical signs of cardiac ischemia

• left ventricular ejection fraction >50% at transthoracic echocardiogram.

Exclusion Criteria:

• disabling stroke (mRS =3)

• non atherosclerotic carotid disease

• severe intracranial carotid artery stenosis

• contra-indications to heparin, aspirin or clopidogrel.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carotid Stenosis
• Constriction, Pathologic
• Coronary Artery Disease
• Coronary Disease
• Coronary Stenosis
• Myocardial Ischemia

Intervention

Other:
• Preoperative coronary angiography
If coronary disease is detected percutaneous intervention (PCI) or coronary artery bypass grafting (CABG) is applied
• Standard cardiac workup
EKG, transthoracic cardiac echocardiogram

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-fatal and fatal myocardial infarction		30 days through year 3	Yes
Secondary	All-cause and cardiovascular mortality		30 days through year 3	Yes