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Does Vitamin D Deficiency Associated With Hypercoagulability & Increased Thrombin Generation?

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ClinicalTrials.gov Identifier: NCT01799655
Recruitment Status : Completed
First Posted : February 27, 2013
Last Update Posted : May 6, 2014
Sponsor:
Information provided by (Responsible Party):
HaEmek Medical Center, Israel

Tracking Information
First Submitted Date February 6, 2013
First Posted Date February 27, 2013
Last Update Posted Date May 6, 2014
Study Start Date April 2013
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 26, 2013)
thrombin generation levels and endogenous thrombin potentials [ Time Frame: 4 month ]
measuring the thrombin generation and endogenous thrombin potential by the calibrated automated thrombogram (CAT)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Does Vitamin D Deficiency Associated With Hypercoagulability & Increased Thrombin Generation?
Official Title Does Vitamin D Deficiency Associated With Hypercoagulability & Increased Thrombin Generation?
Brief Summary

Cardiovascular disease is the most common cause of mortality and morbidity worldwide. Recently, a growing body of evidence has identified Vitamin D deficiency as a potential risk factor for cardiovascular disease. Therefore, there is an increasing interest to explore the mechanism in which vitamin D deficiency affect the cardiovascular system.

The investigators want to examine the relationship between serum vitamin D levels and the coagulation status in the subjects. The applied the calibrated automated thrombogram (CAT) to assess thrombin generation in plasma as a measure of overall thrombotic activity, and thus to suggest a mechanism that may explain the link between vitamin D deficiency and cardiovascular disease.

Our study population are going to include 100 patients from the internal departments in Emek hospital, who present with chest pain but without acute coronary syndrome (ACS). The investigators will take blood samples from the subjects to measure the serum vitamin D levels and the generation of thrombin. The patients will be divided into four groups according to the level of vitamin D to evaluate the effect of vitamin D levels in the blood on coagulability and thrombotic activity in these patients.

Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 1 Day
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population hospitalized patient
Condition Chest Pain
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: February 26, 2013)
100
Original Estimated Enrollment Same as current
Actual Study Completion Date April 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

•hospitalized patient with diagnosed of chest pain

Exclusion Criteria:

•recent Myocardial ischemia - (in the last 30 days)

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT01799655
Other Study ID Numbers Vitamin D deficiency
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party HaEmek Medical Center, Israel
Study Sponsor HaEmek Medical Center, Israel
Collaborators Not Provided
Investigators
Principal Investigator: Mazen elias, prof haemek medical center
PRS Account HaEmek Medical Center, Israel
Verification Date February 2013