Coronary Spasm Presenting Aborted Sudden Cardiac Death, t... | NCT02298543

Studies
Coronary Spasm Presenting Aborted Sudden Cardiac Death, the Multicenter Registry

NCT02298543

Sponsor

Seung-Jung Park

Status

Completed

Last Update Posted

Dec 30, 2015Estimated

Enrollment

200Actual

Phase

Not provided

Conditions

Coronary Vasospasm
Cardiac Death

Interventions

coronary spasm

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2014

Primary Completion Date

Sep 2015Actual

Completion Date

Sep 2015Actual

First Submitted Date

Nov 20, 2014

First Submission Date that Met QC Criteria

Nov 20, 2014

First Posted Date

Nov 24, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 29, 2015

Last Update Posted Date

Dec 30, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Label	Type	Description	Intervention Names
coronary spasm			Other: coronary spasm

Name	Type	Description	Arm Group Labels	Other Names
coronary spasm	Other		coronary spasm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
all cause death		1 year
myocardial infarction		1 year
ventricular tachycardia		1 year
ventricular Fibrillation		1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients diagnosed with coronary spasm

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asan Medical Center		Seoul	Songpa-gu	138-736	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D003329	Coronary Vasospasm
D003643	Death

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided