Actively Recruiting

All Genders
ID06089902

European Prospective Registry on Anomalous Aortic Origin of Coronary Arteries (EUROAAOCA Registry)

Led by University of Padova · Updated on 2023-10-19

500

Participants Needed

2

Research Sites

208 weeks

Total Duration

On this page

Sponsors

U

University of Padova

Lead Sponsor

I

IRCCS Policlinico S. Donato

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying the condition called Anomalous Aortic Origin of a Coronary Artery (AAOCA), which is a rare congenital heart defect with various symptoms and outcomes. The lifetime risk for people with AAOCA is not well known, so this European Registry (EURO-AAOCA) collects data from multiple centers to understand differences in how AAOCA is managed and to improve patient care recommendations. This study collects detailed patient information in eight sections covering demographics, anatomy, symptoms, diagnostic tests, treatments including surgery or other procedures, and follow-up evaluations. Patients may undergo surgical interventions such as unroofing of the coronary artery if needed. Data is gathered for both adult patients over 30 years and younger patients under 30 years, with annual follow-up recommended for at least five years to track health and treatment outcomes. Participants provide medical and diagnostic data, including symptoms, imaging, surgical details, and post-procedure status. The registry tracks outcomes like symptom incidence at diagnosis and after surgery, adverse events, arrhythmias, and return to competitive sports over five years. Data is collected yearly and sent to the coordinating center to monitor long-term patient health and management effects. The study is observational, focusing on real-world patient follow-up and treatment approaches.

CONDITIONS

Brief Title

European Prospective Registry on Anomalous Aortic Origin of the Coronary Arteries

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • All patients with a diagnosis of anomalous aortic origin of coronary arteries (AAOCA), whether referred to surgery or medical follow-up
Not Eligible

You will not qualify if you...

  • Isolated high-coronary take-off (5mm or more above sino-tubular junction)
  • Anomalous origin of a circumflex artery from the right coronary artery
  • Anomalous course with a normal origin
  • Associated major congenital heart diseases such as Tetralogy of Fallot, transposition of the great arteries, or anomalous origin of a coronary artery from the pulmonary artery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Varies based on individual diagnostic procedures

Participants undergo diagnostic tests to confirm the presence and details of anomalous aortic origin of coronary arteries.

1 or more visits depending on diagnostic tests performed

Surgery and Immediate Post-operative Care

Duration - Varies depending on surgery and recovery

Participants who require surgical intervention undergo unroofing or other surgical procedures followed by immediate post-operative care.

1 surgical procedure and approximately 6 post-operative visits

Long-term Monitoring

Duration - At least 5 years

Participants are followed yearly to monitor symptoms, adverse events, arrhythmias, and recovery including return to unrestricted competitive sports.

Annual visits for at least 5 years

Trial Site Locations

Total: 2 locations

1

Massimo Padalino

Padova, PD, Italy, 35128

Actively Recruiting

2

Christopher Grani

Bern, Switzerland

Actively Recruiting

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Research Team

M

Massimo Padalino, MD PhD

C

Chris Grani, MD PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

Therapeutic Management of Anomalous Coronary Arteries Originating From the Opposite Sinus of Valsalva: Current Evidence, Proposed Approach, and the Unknowing.

Marius Reto Bigler, Alexander Kadner, Lorenz Räber...

https://pubmed.ncbi.nlm.nih.gov/36205254

Surgery for anomalous aortic origin of coronary arteries: a multicentre study from the European Congenital Heart Surgeons Association†.

Massimo A Padalino, Nicola Franchetti, Mark Hazekamp...

https://pubmed.ncbi.nlm.nih.gov/30897195