NCT04691791

Brief Summary

Italian registry of coronary artery abnormalities diagnosed utilizing cardiac magnetic resonance imaging.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 28, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 31, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2022

Completed
Last Updated

March 3, 2023

Status Verified

March 1, 2023

Enrollment Period

3.1 years

First QC Date

December 28, 2020

Last Update Submit

March 2, 2023

Conditions

Congenital Coronary Artery Abnormality

Outcome Measures

Primary Outcomes (1)

  • Clinical correlates with imaging findings at the cardiac magnetic resonance imaging.

    Chest pain, palpitations, sincope and arrhythmias

    Up to 3 years from the time of the enrollment

Secondary Outcomes (1)

  • prevalence of congenital anomalies of coronary origin in specific patient subpopulations: 1) in competitive athletes; 2) patients with ventricular ectopic beats

    Up to 3 years from the time of the enrollment

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients undergoing cardiac magnetic resonance imaging who have expressed informed consent to data processing, who have a set of images from which the anomalous origin of the coronaries can be diagnosed.

You may qualify if:

  • Patients with anomalous origin of the coronaries diagnosed with cardiac magnetic resonance imaging

You may not qualify if:

  • Patients with known ischemic heart disease
  • Patients with coronary atherosclerotic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedali Riuniti

Ancona, Italy

Location

Related Publications (7)

  • Cheezum MK, Liberthson RR, Shah NR, Villines TC, O'Gara PT, Landzberg MJ, Blankstein R. Anomalous Aortic Origin of a Coronary Artery From the Inappropriate Sinus of Valsalva. J Am Coll Cardiol. 2017 Mar 28;69(12):1592-1608. doi: 10.1016/j.jacc.2017.01.031.

    PMID: 28335843RESULT

  • Brothers JA, Frommelt MA, Jaquiss RDB, Myerburg RJ, Fraser CD Jr, Tweddell JS. Expert consensus guidelines: Anomalous aortic origin of a coronary artery. J Thorac Cardiovasc Surg. 2017 Jun;153(6):1440-1457. doi: 10.1016/j.jtcvs.2016.06.066. Epub 2017 Feb 4. No abstract available.

    PMID: 28274557RESULT

  • Eckart RE, Scoville SL, Campbell CL, Shry EA, Stajduhar KC, Potter RN, Pearse LA, Virmani R. Sudden death in young adults: a 25-year review of autopsies in military recruits. Ann Intern Med. 2004 Dec 7;141(11):829-34. doi: 10.7326/0003-4819-141-11-200412070-00005.

    PMID: 15583223RESULT

  • Basso C, Maron BJ, Corrado D, Thiene G. Clinical profile of congenital coronary artery anomalies with origin from the wrong aortic sinus leading to sudden death in young competitive athletes. J Am Coll Cardiol. 2000 May;35(6):1493-501. doi: 10.1016/s0735-1097(00)00566-0.

    PMID: 10807452RESULT

  • Maron BJ, Doerer JJ, Haas TS, Tierney DM, Mueller FO. Sudden deaths in young competitive athletes: analysis of 1866 deaths in the United States, 1980-2006. Circulation. 2009 Mar 3;119(8):1085-92. doi: 10.1161/CIRCULATIONAHA.108.804617. Epub 2009 Feb 16.

    PMID: 19221222RESULT

  • Malhotra A, Dhutia H, Finocchiaro G, Gati S, Beasley I, Clift P, Cowie C, Kenny A, Mayet J, Oxborough D, Patel K, Pieles G, Rakhit D, Ramsdale D, Shapiro L, Somauroo J, Stuart G, Varnava A, Walsh J, Yousef Z, Tome M, Papadakis M, Sharma S. Outcomes of Cardiac Screening in Adolescent Soccer Players. N Engl J Med. 2018 Aug 9;379(6):524-534. doi: 10.1056/NEJMoa1714719.

    PMID: 30089062RESULT

  • Villa AD, Sammut E, Nair A, Rajani R, Bonamini R, Chiribiri A. Coronary artery anomalies overview: The normal and the abnormal. World J Radiol. 2016 Jun 28;8(6):537-55. doi: 10.4329/wjr.v8.i6.537.

    PMID: 27358682RESULT

Study Officials

  • Francesco Bianco, M.D.

    Ospedali Riuniti Ancona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

December 28, 2020

First Posted

December 31, 2020

Study Start

September 1, 2019

Primary Completion

September 30, 2022

Study Completion

October 31, 2022

Last Updated

March 3, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)