Acute Myocardial InfarctionNCT01971619
Association of Vitamin D, Parathyroid Hormone and Fibroblast Growth Factor-23 With Infarction-related Arrhythmia in Patients With Acute Myocardial Infarction
An observational study of Acute Myocardial Infarction, run by Yonsei University at 1 site in South Korea.
Trial summary
To investigate the effect of vitamin D deficiency on the development of arrhythmia in patients with acute myocardial infarction. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Acute Myocardial Infarction
- How many people
- 510 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2013to Aug 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with acute myocardial infarction
Who may be able to join
- age ≥20 years
- diagnosed with acute myocardial infarction (confirmed by cardiac enzyme and EKG)
- subjects who agreed with informed consent
Who cannot join
- previous history of arrhythmia before onset of acute myocardial infarction
- currently taking anti-arrhythmic drugs
- severe condition of comorbid diseases that can cause more serious effects on patients than acute myocardial infarction does (e.g., cancer, cerebrovascular diseases, acute bleeding etc.)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Internal Medicine, Yonsei University College of Medicine
Seoul, 120-752
Jin Wi, MD, 82-2-2228-8429, caesar@yuhs.ac
About this study
To investigate the effect of vitamin D deficiency on the development of arrhythmia in patients with acute myocardial infarction.
- Conditions
- Acute Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SACS cohort | patients with acute myocardial infarction at Severance hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Events of acute myocardial infarction-associated arrhythmia
incidence of acute myocardial infarction-associated arrhythmia types of arrhythmia, duration of arrhythmia, persistence of arrhythmia
Measured: first 48 hours after onset of acute myocardial infarction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2013 (estimated)
- Study startAug 2013
- Primary completionOct 2013
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 510 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01971619
- Sponsor's protocol ID
- 4-2013-0424
- Status last verified
- Oct 2013
- First submitted
- 23 Oct 2013
- Last updated
- 29 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Rienstra M, Cheng S, Larson MG, McCabe EL, Booth SL, Jacques PF, Lubitz SA, Yin X, Levy D, Magnani JW, Ellinor PT, Benjamin EJ, Wang TJ. Vitamin D status is not related to development of atrial fibrillation in the community. Am Heart J. 2011 Sep;162(3):538-41. doi: 10.1016/j.ahj.2011.06.013. Epub 2011 Aug 11.
PubMed 21884873
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Vitamin D, Parathyroid Hormone and Fibroblast Growth Factor-23 With Infarction-related Arrhythmia in Patients With Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT01971619
- Acronym / sponsor ID
- 4-2013-0424
- Conditions
- Acute Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 510 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Aug 2015 (estimated)
- First posted
- 29 Oct 2013 (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.
To investigate the effect of vitamin D deficiency on the development of arrhythmia in patients with acute myocardial infarction.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SACS cohort | – | –patients with acute myocardial infarction at Severance hospital |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with acute myocardial infarction
Key inclusion criteria (3 listed)
- age ≥20 years
- diagnosed with acute myocardial infarction (confirmed by cardiac enzyme and EKG)
- subjects who agreed with informed consent
Key exclusion criteria (3 listed)
- previous history of arrhythmia before onset of acute myocardial infarction
- currently taking anti-arrhythmic drugs
- severe condition of comorbid diseases that can cause more serious effects on patients than acute myocardial infarction does (e.g., cancer, cerebrovascular diseases, acute bleeding etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Events of acute myocardial infarction-associated arrhythmia
Time frame: first 48 hours after onset of acute myocardial infarction
incidence of acute myocardial infarction-associated arrhythmia types of arrhythmia, duration of arrhythmia, persistence of arrhythmia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2013.
- Background: PubMed 21884873Rienstra M, Cheng S, Larson MG, McCabe EL, Booth SL, Jacques PF, Lubitz SA, Yin X, Levy D, Magnani JW, Ellinor PT, Benjamin EJ, Wang TJ. Vitamin D status is not related to development of atrial fibrillation in the community. Am Heart J. 2011 Sep;162(3):538-41. doi: 10.1016/j.ahj.2011.06.013. Epub 2011 Aug 11.
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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.
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 Acute Myocardial Infarction, run by Yonsei University 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 3 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: status not confirmed, as of the sponsor's last update on 29 Oct 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jin Wi, MD (82-2-2228-8429, caesar@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Events of acute myocardial infarction-associated arrhythmia (time frame: first 48 hours after onset of acute myocardial infarction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01971619, which also lists 1 linked publication.
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 29 Oct 2013.