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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT01799655
First received: February 6, 2013
Last updated: May 4, 2014
Last verified: February 2013
  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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT01799655     History of Changes
Other Study ID Numbers: Vitamin D deficiency
Study First Received: February 6, 2013
Last Updated: May 4, 2014
Health Authority: Israel: Ethics Commission

Additional relevant MeSH terms:
Thrombophilia
Chest Pain
Vitamin D Deficiency
Pain
Signs and Symptoms
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Hematologic Diseases
Vitamin D
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on July 22, 2014