Coronary Artery Aneurysm Registry

Coronary Artery Aneurysm Clinical Trial

— CAAR  

Official title:

Coronary Artery Aneurysms: Incidence, Management and Long Term Prognosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02563626
• Other study ID #: CAAR
• Status: Completed
• Start date: September 2015
• Est. completion date: December 2016

Study information

• Verified date: January 2022
• Source: St Carlos Hospital, Madrid, Spain
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

International registry gathering patients with angiographically confirmed coronary aneurysm.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1565
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Coronary Aneurysm
• Coronary Artery Aneurysm

Locations

Country	Name	City	State
Spain	Hospital Clínico San Carlos	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
St Carlos Hospital, Madrid, Spain

Country where clinical trial is conducted

Spain, 

References & Publications (9)

Arslan F, Núñez-Gil IJ, Rodríguez-Olivares R, Cerrato E, Bollati M, Nombela-Franco L, Terol B, Alfonso-Rodríguez E, Camacho Freire SJ, Villablanca PA, Amat Santos IJ, De la Torre Hernández JM, Pascual I, Liebetrau C, Alkhouli M, Fernández-Ortiz A; Coronar — View Citation

D'Ascenzo F, Saglietto A, Ramakrishna H, Andreis A, Jiménez-Mazuecos JM, Nombela-Franco L, Cerrato E, Liebetrau C, Alfonso-Rodríguez E, Bagur R, Alkhouli M, De Ferrari GM, Núñez-Gil IJ; CAAR Investigators. Usefulness of oral anticoagulation in patients wi — View Citation

Dutary J, Zakhem B, DE Lucas CB, Paulo M, Gonzalo N, Alfonso F. Treatment of a giant coronary artery aneurysm: intravascular ultrasound and optical coherence tomography findings. J Interv Cardiol. 2012 Feb;25(1):82-5. doi: 10.1111/j.1540-8183.2011.00659.x. Epub 2011 May 22. — View Citation

Maehara A, Mintz GS, Ahmed JM, Fuchs S, Castagna MT, Pichard AD, Satler LF, Waksman R, Suddath WO, Kent KM, Weissman NJ. An intravascular ultrasound classification of angiographic coronary artery aneurysms. Am J Cardiol. 2001 Aug 15;88(4):365-70. — View Citation

Núñez-Gil IJ, Cerrato E, Bollati M, Nombela-Franco L, Terol B, Alfonso-Rodríguez E, Camacho Freire SJ, Villablanca PA, Amat Santos IJ, de la Torre Hernández JM, Pascual I, Liebetrau C, Camacho B, Pavani M, Albistur J, Latini RA, Varbella F, Jiménez-Díaz V — View Citation

Núñez-Gil IJ, Nombela-Franco L, Bagur R, Bollati M, Cerrato E, Alfonso E, Liebetrau C, De la Torre Hernandez JM, Camacho B, Mila R, Amat-Santos IJ, Alfonso F, Rodríguez-Olivares R, Camacho Freire SJ, Lozano Í, Jiménez Díaz VA, Piraino D, Latini RA, Feltes — View Citation

SCOTT DH. Aneurysm of the coronary arteries. Am Heart J. 1948 Sep;36(3):403-21. — View Citation

Swaye PS, Fisher LD, Litwin P, Vignola PA, Judkins MP, Kemp HG, Mudd JG, Gosselin AJ. Aneurysmal coronary artery disease. Circulation. 1983 Jan;67(1):134-8. — View Citation

Syed M, Lesch M. Coronary artery aneurysm: a review. Prog Cardiovasc Dis. 1997 Jul-Aug;40(1):77-84. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Any cause death	dicotomic variable (yes/no)	12 months
Primary	Cardiology readmission	dicotomic variable (yes/no)	12 months