NCT02298543

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 24, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

December 30, 2015

Status Verified

December 1, 2015

Enrollment Period

10 months

First QC Date

November 20, 2014

Last Update Submit

December 29, 2015

Conditions

Coronary VasospasmCardiac Death

Outcome Measures

Primary Outcomes (4)

  • all cause death

    1 year

  • myocardial infarction

    1 year

  • ventricular tachycardia

    1 year

  • ventricular Fibrillation

    1 year

Study Arms (1)

coronary spasm

Other: coronary spasm

Interventions

coronary spasmOTHER
coronary spasm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with coronary spasm

You may qualify if:

  • Age 18 and more
  • Coronary spasm

You may not qualify if:

  • Life expectancy less than 2years
  • Coronary stenosis 50% and more
  • Structural abnormalities of the heart leading to ventricular arrhythmia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, Songpa-gu, 138-736, South Korea

Location

MeSH Terms

Conditions

Coronary VasospasmDeath

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

November 20, 2014

First Posted

November 24, 2014

Study Start

November 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

December 30, 2015

Record last verified: 2015-12

Locations

KR(1)