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NCT02298543 Clinical Trial

Coronary Spasm Presenting Aborted Sudden Cardiac Death, the Multicenter Registry

Cardiac Death Clinical Trial

Official title:
The Multicenter Registry to Evaluate the Natural Course of Coronary Spasm Patients Presenting Aborted Sudden Cardiac Death

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02298543
Other study ID # AMCCV2014-11
Secondary ID
Status Completed
Phase N/A
First received November 20, 2014
Last updated December 29, 2015
Start date November 2014
Est. completion date September 2015

Study information
Verified date December 2015
Source Asan Medical Center
Contact n/a
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Observational

Clinical Trial Summary

The purpose of this study is to evaluate the natural course of coronary spasm patients presenting aborted sudden cardiac death and analyze risk factors.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date September 2015
Est. primary completion date September 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age 18 and more

- Coronary spasm

Exclusion Criteria:

- Life expectancy less than 2years

- Coronary stenosis 50% and more

- Structural abnormalities of the heart leading to ventricular arrhythmia

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• coronary spasm

Locations
Country Name City State
Korea, Republic of Asan Medical Center Seoul Songpa-gu

Sponsors (1)
Lead Sponsor Collaborator
Seung-Jung Park

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary all cause death 1 year Yes
Primary myocardial infarction 1 year Yes
Primary ventricular tachycardia 1 year No
Primary ventricular Fibrillation 1 year No
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