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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01971619
Other study ID # 4-2013-0424
Secondary ID
Status Recruiting
Phase N/A
First received October 23, 2013
Last updated October 28, 2013
Start date August 2013
Est. completion date August 2015

Study information

Verified date October 2013
Source Yonsei University
Contact Jin Wi, MD
Phone 82-2-2228-8429
Email caesar@yuhs.ac
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Observational

Clinical Trial Summary

To investigate the effect of vitamin D deficiency on the development of arrhythmia in patients with acute myocardial infarction.


Recruitment information / eligibility

Status Recruiting
Enrollment 510
Est. completion date August 2015
Est. primary completion date October 2013
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 90 Years
Eligibility Inclusion Criteria:

- age =20 years

- diagnosed with acute myocardial infarction (confirmed by cardiac enzyme and EKG)

- subjects who agreed with informed consent

Exclusion Criteria:

- 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.)

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Locations

Country Name City State
Korea, Republic of Department of Internal Medicine, Yonsei University College of Medicine Seoul

Sponsors (1)

Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Events of acute myocardial infarction-associated arrhythmia incidence of acute myocardial infarction-associated arrhythmia types of arrhythmia, duration of arrhythmia, persistence of arrhythmia first 48 hours after onset of acute myocardial infarction No
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