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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name