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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000018432 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | Acute myocardial infarction | |
Classification by specialty |
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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 | |
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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. |
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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 |
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Target sample size | 800 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | University of Yamanashi, Department of Internal Medicine II |
Institute | |
Department |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date trial data considered complete | |||||||
Date analysis concluded |
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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 |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021340 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |