Coronary Artery Aneurysm Registry (CAAR)

January 9, 2022 updated by: IVAN J NUÑEZ GIL, St Carlos Hospital, Madrid, Spain

Coronary Artery Aneurysms: Incidence, Management and Long Term Prognosis

International registry gathering patients with angiographically confirmed coronary aneurysm.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

1565

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients with a coronary aneurysm diagnosis.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Any cause death
Time Frame: 12 months
dicotomic variable (yes/no)
12 months
Cardiology readmission
Time Frame: 12 months
dicotomic variable (yes/no)
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St Carlos Hospital, Madrid, Spain

Investigators

  • Study Chair: IVAN J NUÑEZ GIL, MD,PhD,FESC, Hospital Clínico San Carlos.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

September 26, 2015

First Submitted That Met QC Criteria

September 29, 2015

First Posted (Estimate)

September 30, 2015

Study Record Updates

Last Update Posted (Actual)

January 25, 2022

Last Update Submitted That Met QC Criteria

January 9, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAAR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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