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OpenTrials
Completed

NCT Number: NCT02563626

Coronary Artery Aneurysm Registry

International registry gathering patients with angiographically confirmed coronary aneurysm.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Clínico San Carlos

Madrid, 28040, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Any cause death

    Time frame: 12 months

    dicotomic variable (yes/no)

  2. Cardiology readmission

    Time frame: 12 months

    dicotomic variable (yes/no)

Sponsors and collaborators

Lead sponsor

St Carlos Hospital, Madrid, Spain

Other

Registry information

Official study title

Coronary Artery Aneurysms: Incidence, Management and Long Term Prognosis

Acronym: CAAR

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 30, 2015
Registry last updated
Jan 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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