Clinical trial NCT02563626: Coronary Artery Aneurysm Registry
Official title: Coronary Artery Aneurysms: Incidence, Management and Long Term Prognosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Aneurysm
Keywords: coronary artery aneurysm
prognosis
outcomes
management
incidence
heart failure
acute coronary syndrome
death
Lead sponsor: St Carlos Hospital, Madrid, Spain
Sponsor class: OTHER
First posted: 2015-09-30
Enrollment: 1565
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with a coronary aneurysm diagnosis.

Brief summary: International registry gathering patients with angiographically confirmed coronary 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.

Eligibility 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.

Primary outcomes:
measure: Any cause death
timeFrame: 12 months
measure: Cardiology readmission
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
Study officials:
affiliation: HOSPITAL CLINICO SAN CARLOS.
name: IVAN J NUÑEZ GIL, MD,PhD,FESC
role: STUDY_CHAIR
References:
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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. doi: 10.1016/s0002-9149(01)01680-0.
citation: Nunez-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, Rodriguez-Olivares R, Camacho Freire SJ, Lozano I, Jimenez Diaz VA, Piraino D, Latini RA, Feltes G, Linares JA, Mancone M, Ielasi A, Sanchez-Grande Flecha A, Fernandez Cisnal A, Ugo F, Jimenez Mazuecos JM, Omede P, Pavani M, Villablanca PA, Louka BF, Fernandez-Ortiz A; CAAR Investigators. Rationale and design of a multicenter, international and collaborative Coronary Artery Aneurysm Registry (CAAR). Clin Cardiol. 2017 Aug;40(8):580-585. doi: 10.1002/clc.22705. Epub 2017 Mar 24.
citation: Nunez-Gil IJ, Cerrato E, Bollati M, Nombela-Franco L, Terol B, Alfonso-Rodriguez E, Camacho Freire SJ, Villablanca PA, Amat Santos IJ, de la Torre Hernandez JM, Pascual I, Liebetrau C, Camacho B, Pavani M, Albistur J, Latini RA, Varbella F, Jimenez-Diaz VA, Piraino D, Mancone M, Alfonso F, Linares JA, Rodriguez-Olivares R, Jimenez Mazuecos JM, Palazuelos Molinero J, Sanchez-Grande Flecha A, Gomez-Hospital JA, Ielasi A, Lozano I, Omede P, Bagur R, Ugo F, Medda M, Louka BF, Kala P, Escaned J, Bautista D, Feltes G, Salinas P, Alkhouli M, Macaya C, Fernandez-Ortiz A; CAAR investigators. Coronary artery aneurysms, insights from the international coronary artery aneurysm registry (CAAR). Int J Cardiol. 2020 Jan 15;299:49-55. doi: 10.1016/j.ijcard.2019.05.067. Epub 2019 Jul 19.
citation: D'Ascenzo F, Saglietto A, Ramakrishna H, Andreis A, Jimenez-Mazuecos JM, Nombela-Franco L, Cerrato E, Liebetrau C, Alfonso-Rodriguez E, Bagur R, Alkhouli M, De Ferrari GM, Nunez-Gil IJ; CAAR Investigators. Usefulness of oral anticoagulation in patients with coronary aneurysms: Insights from the CAAR registry. Catheter Cardiovasc Interv. 2021 Nov 1;98(5):864-871. doi: 10.1002/ccd.29243. Epub 2020 Sep 9.
citation: Arslan F, Nunez-Gil IJ, Rodriguez-Olivares R, Cerrato E, Bollati M, Nombela-Franco L, Terol B, Alfonso-Rodriguez E, Camacho Freire SJ, Villablanca PA, Amat Santos IJ, De la Torre Hernandez JM, Pascual I, Liebetrau C, Alkhouli M, Fernandez-Ortiz A; Coronary Artery Aneurysm Registry (CAAR) investigators. Sex differences in treatment strategy for coronary artery aneurysms: Insights from the international Coronary Artery Aneurysm Registry. Neth Heart J. 2022 Jun;30(6):328-334. doi: 10.1007/s12471-021-01649-5. Epub 2021 Dec 15.