NCT01971619

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
510

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
unknown

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

August 1, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

October 23, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 29, 2013

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

October 29, 2013

Status Verified

October 1, 2013

Enrollment Period

2 months

First QC Date

October 23, 2013

Last Update Submit

October 28, 2013

Conditions

Acute Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

SACS cohort

patients with acute myocardial infarction at Severance hospital

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with acute myocardial infarction

You may qualify if:

  • age ≥20 years
  • diagnosed with acute myocardial infarction (confirmed by cardiac enzyme and EKG)
  • subjects who agreed with informed consent

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Internal Medicine, Yonsei University College of Medicine

Seoul, 120-752, South Korea

RECRUITING

Related 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.

    PMID: 21884873BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

plasma blood sample (5ml)

Central Study Contacts

Jin Wi, MD

CONTACT

82-2-2228-8429caesar@yuhs.ac

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2013

First Posted

October 29, 2013

Study Start

August 1, 2013

Primary Completion

October 1, 2013

Study Completion

August 1, 2015

Last Updated

October 29, 2013

Record last verified: 2013-10

Locations

KR(1)