AzTrials
AzTrials

Coronary Artery AneurysmCAARNCT02563626

Coronary Artery Aneurysm Registry

An observational study of Coronary Artery Aneurysm, run by St Carlos Hospital, Madrid, Spain at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

International registry gathering patients with angiographically confirmed coronary aneurysm. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Aneurysm
How many people
1,565 participants
Where
1 siteSpain
Study dates
Sep 2015to Dec 2016
How long will I take part?
12 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All patients with a coronary aneurysm diagnosis.

Who may be able to join

  • 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.

Who cannot join

  • Patient ´s refusal to participate.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Clínico San Carlos

    Madrid, 28040

Other trials in Spain

About this study

Official title: Coronary Artery Aneurysms: Incidence, Management and Long Term Prognosis

International registry gathering patients with angiographically confirmed coronary aneurysm.

Read the 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.
Keywords
coronary artery aneurysm, prognosis, outcomes, management, incidence, heart failure, acute coronary syndrome, death
Medical subject headings
Coronary Aneurysm, Heart Failure, Acute Coronary Syndrome, Death

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Any cause death

    dicotomic variable (yes/no)

    Measured: 12 months

  2. Cardiology readmission

    dicotomic variable (yes/no)

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2015 (estimated)
  2. Study startSep 2015
  3. Primary completionDec 2016
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,565 participants (actual)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT02563626
Sponsor's protocol ID
CAAR
Acronym
CAAR
Status last verified
Jan 2022
First submitted
26 Sep 2015
Last updated
25 Jan 2022
Results posted
No
Data monitoring committee
No

Publications

  • SCOTT DH. Aneurysm of the coronary arteries. Am Heart J. 1948 Sep;36(3):403-21. doi: 10.1016/0002-8703(48)90337-8. No abstract available.

    PubMed 18880707

  • 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. doi: 10.1161/01.cir.67.1.134.

    PubMed 6847792

  • Syed M, Lesch M. Coronary artery aneurysm: a review. Prog Cardiovasc Dis. 1997 Jul-Aug;40(1):77-84. doi: 10.1016/s0033-0620(97)80024-2.

    PubMed 9247557

  • 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.

    PubMed 21599751

  • 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.

    PubMed 11545755

  • 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.

    PubMed 28337781

  • 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.

    PubMed 31378382

  • 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.

    PubMed 32902099

  • 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.

    PubMed 34910278

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Aneurysm, run by St Carlos Hospital, Madrid, Spain at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Any cause death (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02563626, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2022; AzTrials last refreshed its copy on 30 Oct 2026.

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