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

Chest Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01799655
• Other study ID #: Vitamin D deficiency
• Status: Completed
• Phase: N/A
• First received: February 6, 2013
• Last updated: May 4, 2014
• Start date: April 2013
• Est. completion date: April 2014

Study information

• Verified date: February 2013
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

•hospitalized patient with diagnosed of chest pain

Exclusion Criteria:

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chest Pain
• Thrombophilia
• Vitamin D Deficiency

Locations

Country	Name	City	State
Israel	Haemek medical center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	thrombin generation levels and endogenous thrombin potentials	measuring the thrombin generation and endogenous thrombin potential by the calibrated automated thrombogram (CAT)	4 month	No