NCT04691791 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

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-
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
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
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: 10.7326/0003-4819-141-11-2004120
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 Car
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.
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.

Italian Registry of Cardiovascular Magnetic Resonance on Congenital Anomalies of the Coronary Arteries (ITACA-Registry)

Details for clinical trial NCT04691791

Clinical trial NCT04691791 - References