Coronary Angiography Before Elective Carotid Endarterectomy in Patients With Asymptomatic Coronary Artery Disease
CACEA
Randomized Controlled Trial Analyzing the Role of Systematic Preoperative Coronary Angiography Before Elective Carotid Endarterectomy in Patients With Asymptomatic Coronary Artery Disease
1 other identifier
interventional
426
0 countries
N/A
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2005
Longer than P75 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 6, 2014
CompletedFirst Posted
Study publicly available on registry
October 9, 2014
CompletedOctober 9, 2014
October 1, 2014
4.5 years
October 6, 2014
October 8, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Non-fatal and fatal myocardial infarction
30 days through year 3
Secondary Outcomes (1)
All-cause and cardiovascular mortality
30 days through year 3
Study Arms (2)
A - Coronary angiography
ACTIVE COMPARATORAll the patients receive preoperative coronary angiography followed, if needed, by percutaneous intervention (PCI) or bypass (CABG)
B - standard cardiac workup
ACTIVE COMPARATORStandard cardiac workup
Interventions
If coronary disease is detected percutaneous intervention (PCI) or coronary artery bypass grafting (CABG) is applied
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- disabling stroke (mRS ≥3)
- non atherosclerotic carotid disease
- severe intracranial carotid artery stenosis
- contra-indications to heparin, aspirin or clopidogrel.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Illuminati G, Schneider F, Greco C, Mangieri E, Schiariti M, Tanzilli G, Barilla F, Paravati V, Pizzardi G, Calio' F, Miraldi F, Macrina F, Totaro M, Greco E, Mazzesi G, Tritapepe L, Toscano M, Vietri F, Meyer N, Ricco JB. Long-term results of a randomized controlled trial analyzing the role of systematic pre-operative coronary angiography before elective carotid endarterectomy in patients with asymptomatic coronary artery disease. Eur J Vasc Endovasc Surg. 2015 Apr;49(4):366-74. doi: 10.1016/j.ejvs.2014.12.030. Epub 2015 Feb 18.
PMID: 25701070DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Giulio Illuminati, MD
University of Roma La Sapienza
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Surgery
Study Record Dates
First Submitted
October 6, 2014
First Posted
October 9, 2014
Study Start
January 1, 2005
Primary Completion
July 1, 2009
Study Completion
June 1, 2012
Last Updated
October 9, 2014
Record last verified: 2014-10