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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01799655
First Posted: February 27, 2013
Last Update Posted: May 6, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
HaEmek Medical Center, Israel
  Purpose

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
Chest Pain

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Does Vitamin D Deficiency Associated With Hypercoagulability & Increased Thrombin Generation?

Resource links provided by NLM:


Further study details as provided by HaEmek Medical Center, Israel:

Primary Outcome Measures:
  • 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)


Estimated Enrollment: 100
Study Start Date: April 2013
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Information from the National Library of Medicine

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

Responsible Party: HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT01799655     History of Changes
Other Study ID Numbers: Vitamin D deficiency
First Submitted: February 6, 2013
First Posted: February 27, 2013
Last Update Posted: May 6, 2014
Last Verified: February 2013

Additional relevant MeSH terms:
Thrombophilia
Vitamin D Deficiency
Chest Pain
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Hematologic Diseases
Vitamin D
Thrombin
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Hemostatics
Coagulants