UMIN-CTR Clinical Trial

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
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
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
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

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