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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

Study Description
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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.


Condition or disease
Chest Pain

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Does Vitamin D Deficiency Associated With Hypercoagulability & Increased Thrombin Generation?
Study Start Date : April 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
hospitalized patient
Criteria

Inclusion Criteria:

•hospitalized patient with diagnosed of chest pain

Exclusion Criteria:

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

Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01799655


Locations
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Israel
Haemek medical center
Afula, Israel, 18101
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
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Principal Investigator: Mazen elias, prof haemek medical center
More Information
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Additional Information:

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Responsible Party: HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT01799655    
Other Study ID Numbers: Vitamin D deficiency
First Posted: February 27, 2013    Key Record Dates
Last Update Posted: May 6, 2014
Last Verified: February 2013
Additional relevant MeSH terms:
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Thrombophilia
Vitamin D Deficiency
Chest Pain
Avitaminosis
Deficiency Diseases
 Malnutrition
Nutrition Disorders
Pain
Neurologic Manifestations
Hematologic Diseases