Coronary Artery Aneurysm Registry (CAAR)
|ClinicalTrials.gov Identifier: NCT02563626|
Recruitment Status : Completed
First Posted : September 30, 2015
Last Update Posted : September 23, 2019
|Condition or disease|
|Coronary Artery Aneurysm|
INTRODUCTION AND RATIONALE:
Coronary artery aneurysm is defined as coronary dilatation which exceeds the diameter of normal adjacent segments or the diameter of the patient's largest coronary vessel by 1.5 times. Described by Bourgon, it is an uncommon disease which has been diagnosed with increasing frequency since the advent of coronary angiography. The incidence varies from 1.5% to 5% with male dominance and a predilection for the right coronary artery.
Although several causes have been reported, atherosclerosis accounts for 50% of coronary aneurysms in adults. Reported complications include thrombosis and distal embolization, rupture and vasospasm, causing ischemia, heart failure or arrhythmias. The natural history and prognosis remains obscure, since definitive data are scarce. Controversies persist regarding the use of medical management (antithrombotic) or interventional/surgical procedures.
Taking into account the classical coronary aneurysm definition, the investigators propose:
- To characterize coronary aneurysms frequency over all cause invasive coronary angiography.
- To describe anatomy, location and aneurysms features.
- To assess intracoronary imaging data if available.
- To describe the natural history, when evolutive chats were available
- Cause for the diagnostic catheterization and aneurysms symptoms, if present.
- Patient´s clinical features.
- Long-term outcomes.
- To assess management strategies, conservative, interventional or surgical and its short and long term results.
- Outcomes regarding management.
- Retrospective recruitment, prospective follow-up registry.
- Electronic database. Centralized analysis (core) at Hospital Clínico San Carlos.
- Recruitment: 1/january/2002-1/december/2015.
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||1565 participants|
|Target Follow-Up Duration:||12 Months|
|Official Title:||Coronary Artery Aneurysms: Incidence, Management and Long Term Prognosis|
|Actual Study Start Date :||September 2015|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
- Any cause death [ Time Frame: 12 months ]dicotomic variable (yes/no)
- Cardiology readmission [ Time Frame: 12 months ]dicotomic variable (yes/no)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02563626
|Hospital Clínico San Carlos|
|Madrid, Spain, 28040|
|Study Chair:||IVAN J NUÑEZ GIL, MD,PhD,FESC||HOSPITAL CLINICO SAN CARLOS.|