Coronary VasospasmNCT02298543
Coronary Spasm Presenting Aborted Sudden Cardiac Death, the Multicenter Registry
An observational study of Coronary Vasospasm and Cardiac Death, run by Seung-Jung Park at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Vasospasm, Cardiac Death
- What is being tested?
- coronary spasm
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2014to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with coronary spasm
Who may be able to join
- Age 18 and more
- Coronary spasm
Who cannot join
- Life expectancy less than 2years
- Coronary stenosis 50% and more
- Structural abnormalities of the heart leading to ventricular arrhythmia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Multicenter Registry to Evaluate the Natural Course of Coronary Spasm Patients Presenting Aborted Sudden Cardiac Death
The purpose of this study is to evaluate the natural course of coronary spasm patients presenting aborted sudden cardiac death and analyze risk factors.
- Conditions
- Coronary Vasospasm, Cardiac Death
- Being tested
- coronary spasm
- Medical subject headings
- Coronary Vasospasm, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coronary spasmOther
| Study group | Role | What they receive |
|---|---|---|
| coronary spasm | Not described Receives: Other: coronary spasm |
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause death
Measured: 1 year
myocardial infarction
Measured: 1 year
ventricular tachycardia
Measured: 1 year
ventricular Fibrillation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary VasospasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seung-Jung Park
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Seung-Jung Park, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02298543
- Sponsor's protocol ID
- AMCCV2014-11
- Status last verified
- Dec 2015
- First submitted
- 20 Nov 2014
- Last updated
- 30 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Multicenter Registry to Evaluate the Natural Course of Coronary Spasm Patients Presenting Aborted Sudden Cardiac Death
- ClinicalTrials.gov ID
- NCT02298543
- Acronym / sponsor ID
- AMCCV2014-11
- Conditions
- Coronary Vasospasm, Cardiac Death
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Seung-Jung ParkUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 24 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the natural course of coronary spasm patients presenting aborted sudden cardiac death and analyze risk factors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| coronary spasm | – | Other: coronary spasm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with coronary spasm
Key inclusion criteria (2 listed)
- Age 18 and more
- Coronary spasm
Key exclusion criteria (3 listed)
- Life expectancy less than 2years
- Coronary stenosis 50% and more
- Structural abnormalities of the heart leading to ventricular arrhythmia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| coronary spasm | Other | coronary spasm |
Primary outcome
all cause death
Time frame: 1 year
myocardial infarction
Time frame: 1 year
ventricular tachycardia
Time frame: 1 year
ventricular Fibrillation
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Vasospasm and Cardiac Death, run by Seung-Jung Park at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all cause death (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2015.