UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018432 |
|---|---|
| Receipt number | R000021340 |
| Scientific Title | Observational study to evaluate clinical significance of coronary spasm in the culprit coronary artery in patients with acute myocardial infarction |
| Date of disclosure of the study information | 2015/08/01 |
| Last modified on | 2018/07/31 13:00:54 |
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Basic information
Public title
Observational study to evaluate clinical significance of coronary spasm in the culprit coronary artery in patients with acute myocardial infarction
Acronym
Observational study of coronary artery spasm after AMI
Scientific Title
Observational study to evaluate clinical significance of coronary spasm in the culprit coronary artery in patients with acute myocardial infarction
Scientific Title:Acronym
Observational study of coronary artery spasm after AMI
Region
| Japan |
Condition
Condition
Acute myocardial infarction
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate the effect of coronary spasm in the culprit coronary artery on clinical outcomes in patients with acute myocardial infarction
Basic objectives2
Others
Basic objectives -Others
Clinical significance of coronary artery spasm in AMI patients
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Composite endpoints during 5 years after AMI; Cardiac death, non-fatal myocardial infarction, unstable angina requiring admission
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The study patients, who admitted to Yamanashi University Hospital, met all of the following inclusion criteria;
1. Patients with acute myocardial infarction (AMI), who received emergent coronary angiography and successful reperfusion therapy by primary percutaneous coronary intervention using stent within 24 hrs after onset of AMI.
2. Provocation test for coronary spasm in the culprit coronary artery with acetylcholine at the discharge.
Key exclusion criteria
The study patients met the following exclusion criteria were excluded;
1. Residual organic stenosis > 50% in the culprit coronary artery;
2. Previous coronary artery bypass surgery;
3. Congestive heart failure at 1 week after AMI;
4. Valvular heart diseases, neoplasm, secondary hypertension, renal dysfunction (serum creatinine concentration > 2.0 mg/dL) or other serious diseases;
5. Left main trunk disease
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiyotaka Kugiyama |
Organization
Yamanashi University Hospital
Division name
Internal Medicine II
Zip code
Address
1110 Shimokato, Chuo city, Yamanashi Prefecture
TEL
055-273-9590
kugiyama@yamanashi.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kiyotaka Kugiyama |
Organization
Yamanashi University Hospital
Division name
Internal Medicine II
Zip code
Address
1110 Shimokato, Chuo city, Yamanashi Prefecture
TEL
055-273-9590
Homepage URL
kugiyama@yamanashi.ac.jp
Sponsor or person
Institute
University of Yamanashi, Department of Internal Medicine II
Institute
Department
Personal name
Funding Source
Organization
University of Yamanashi, Department of Internal Medicine II
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
| 2015 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The presence of inducible CAS did not increase the incidence of the cardiac events in AMI survivors. Treatment with CCBs may improve outcomes in AMI survivors with inducible CAS.
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
| 2005 | Year | 09 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 09 | Month | 20 | Day |
Last follow-up date
| 2015 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 12 | Month | 31 | Day |
Other
Other related information
All registered patients were prospectively followed up every 2 months in the hospital or with a clinic visit for a period of up to 5 years or until the occurrence of 1 of the primary outcomes.
Management information
Registered date
| 2015 | Year | 07 | Month | 27 | Day |
Last modified on
| 2018 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021340
