UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030629 |
|---|---|
| Receipt number | 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 12:15:53 |
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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
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
nagashima.kouichi@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034953
