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Coronary Artery Aneurysm Registry (CAAR)

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ClinicalTrials.gov Identifier: NCT02563626
Recruitment Status : Completed
First Posted : September 30, 2015
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
IVAN J NUÑEZ GIL, St Carlos Hospital, Madrid, Spain

Brief Summary:
International registry gathering patients with angiographically confirmed coronary aneurysm.

Condition or disease
Coronary Artery Aneurysm

Detailed Description:

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.

OBJECTIVES.

Taking into account the classical coronary aneurysm definition, the investigators propose:

  • ANATOMIC OBJECTIVES.

    • 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
  • CLINICAL OBJECTIVES.

    • Cause for the diagnostic catheterization and aneurysms symptoms, if present.
    • Patient´s clinical features.
    • Long-term outcomes.
  • THERAPEUTIC OBJECTIVES.

    • To assess management strategies, conservative, interventional or surgical and its short and long term results.
    • Outcomes regarding management.

DESIGN:

  • Retrospective recruitment, prospective follow-up registry.
  • Multicentric/international.
  • Anonymized.
  • Electronic database. Centralized analysis (core) at Hospital Clínico San Carlos.
  • Recruitment: 1/january/2002-1/december/2015.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 1565 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms




Primary Outcome Measures :
  1. Any cause death [ Time Frame: 12 months ]
    dicotomic variable (yes/no)

  2. Cardiology readmission [ Time Frame: 12 months ]
    dicotomic variable (yes/no)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients with a coronary aneurysm diagnosis.
Criteria

Inclusion Criteria (angiographic diagnosis):

  • Coronary aneurysm: focal coronary dilatation which exceeds the diameter of normal adjacent segments or the diameter of the patient's largest coronary vessel by 1.5 times.

Exclusion Criteria:

  • Patient ´s refusal to participate.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02563626


Locations
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Spain
Hospital Clínico San Carlos
Madrid, Spain, 28040
Sponsors and Collaborators
St Carlos Hospital, Madrid, Spain
Investigators
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Study Chair: IVAN J NUÑEZ GIL, MD,PhD,FESC HOSPITAL CLINICO SAN CARLOS.
Additional Information:

Publications of Results:
Other Publications:

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Responsible Party: IVAN J NUÑEZ GIL, MD, PhD, FESC, St Carlos Hospital, Madrid, Spain
ClinicalTrials.gov Identifier: NCT02563626    
Other Study ID Numbers: CAAR
First Posted: September 30, 2015    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019
Keywords provided by IVAN J NUÑEZ GIL, St Carlos Hospital, Madrid, Spain:
coronary artery aneurysm
prognosis
outcomes
management
incidence
heart failure
acute coronary syndrome
death
Additional relevant MeSH terms:
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Aneurysm
Coronary Aneurysm
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Myocardial Ischemia
Heart Diseases