UMIN-CTR Clinical Trial

Basic information
Public title	Secondary Prevention of Adverse Cardiovascular Events in Cases with Anomalous Origins of Coronary Arteries: Clinical Features, Management, and Long-Term Outcome
Acronym	Secondary Prevention of Adverse Cardiovascular Events in Cases with Anomalous Origins of Coronary Arteries: Clinical Features, Management, and Long-Term Outcome (J-CONOMALY Registry)
Scientific Title	Secondary Prevention of Adverse Cardiovascular Events in Cases with Anomalous Origins of Coronary Arteries: Clinical Features, Management, and Long-Term Outcome
Scientific Title:Acronym	Secondary Prevention of Adverse Cardiovascular Events in Cases with Anomalous Origins of Coronary Arteries: Clinical Features, Management, and Long-Term Outcome (J-CONOMALY Registry)
Region	Japan

Condition
Condition	Anomalous Origin of the Coronary Artery
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Anomalous origins of the coronary artery (AOCA) coursing between the great vessels are known to be a rare but potential risk for life-threatening cardiac events. The aim of this retrospective registry was to assess the clinical features, management and prognosis of AOCA patients who experienced cardiac events.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Long-term prognosis(all-cause mortality, cardiac death, non-cardiac death, cardiovascular events)
Key secondary outcomes	Patency of repaired coronary artery arrhythmia detection by implantable cardioverter-defibrillator

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) patients who had anomalous origin of coronary artery (AOCA) coursing between the great vessels detected by the coronary angiography and/or CT, (2) AOCA patients who required hospitalization and treatment for ischemic cardiac events, and (3) the cardiac events were caused by the occlusion, obstruction or stenosis of anomalous coronary revealed by coronary CAG and/or CT, or the physician determined that the cardiac events were caused by ischemia of anomalous coronary, given the results of CAG and other non-invasive modalities including CT, myocardial perfusion scintigraphy and treadmill stress test and symptoms. The ischemic cardiac events were classified as cardio-pulmonary arrest, acute myocardial infarction, angina, arrhythmia, syncope or heart failure.
Key exclusion criteria	(1) AOCA patients who had non-cardiovascular events. (2) Patients who rejected to prticipate in this registry (3) Patients judged as inappropriate for this registry by investigators
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name Koichi Nagashima
Organization	Nihon University School of Medicine
Division name	Division of Cardiology, Department of Medicine
Zip code
Address	30-1 Ohyaguchi Kamicho, Itabashi-Ku, Tokyo 173-8610, Japan
TEL	+81-3-3972-8111
Email	nagashima.kouichi@nihon-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Koichi Nagashima
Organization	Nihon University School of Medicine
Division name	Division of Cardiology, Department of Medicine
Zip code
Address	30-1 Ohyaguchi Kamicho, Itabashi-Ku, Tokyo 173-8610, Japan
TEL	+81-3-3972-8111
Homepage URL
Email	nagashima.kouichi@nihon-u.ac.jp

Sponsor
Institute	Nihon University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2018 Year 01 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 02 Month 24 Day
Date of IRB	2017 Year 02 Month 27 Day
Anticipated trial start date	2017 Year 02 Month 27 Day
Last follow-up date	2019 Year 06 Month 20 Day
Date of closure to data entry	2019 Year 06 Month 20 Day
Date trial data considered complete
Date analysis concluded	2019 Year 06 Month 20 Day

Other
Other related information	Retrospective observation study

Management information
Registered date	2017 Year 12 Month 28 Day
Last modified on	2019 Year 06 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034953