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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030629
Receipt No. R000034953
Scientific Title Secondary Prevention of Adverse Cardiovascular Events in Cases with Anomalous Origins of Coronary Arteries: Clinical Features, Management, and Long-Term Outcome
Date of disclosure of the study information 2018/01/01
Last modified on 2019/06/30

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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/ctr_e/ctr_view.cgi?recptno=R000034953

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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