Chest PainNCT01799655
Does Vitamin D Deficiency Associated With Hypercoagulability & Increased Thrombin Generation?
An observational study of Chest Pain, run by HaEmek Medical Center, Israel at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chest Pain
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2013to Apr 2014
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: hospitalized patient
Who may be able to join
- •hospitalized patient with diagnosed of chest pain
Who cannot join
- •recent Myocardial ischemia - (in the last 30 days)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Chest Pain
- Medical subject headings
- Chest Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
thrombin generation levels and endogenous thrombin potentials
measuring the thrombin generation and endogenous thrombin potential by the calibrated automated thrombogram (CAT)
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2013 (estimated)
- Study startApr 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mazen elias, prof, Principal investigator, haemek medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01799655
- Sponsor's protocol ID
- Vitamin D deficiency
- Status last verified
- Feb 2013
- First submitted
- 6 Feb 2013
- Last updated
- 6 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Vitamin D Deficiency Associated With Hypercoagulability & Increased Thrombin Generation?
- ClinicalTrials.gov ID
- NCT01799655
- Acronym / sponsor ID
- Vitamin D deficiency
- Conditions
- Chest Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 27 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- hospitalized patient
Key inclusion criteria (1 listed)
- •hospitalized patient with diagnosed of chest pain
Key exclusion criteria (1 listed)
- •recent Myocardial ischemia - (in the last 30 days)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mazen elias, prof principal investigator
haemek medical center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chest Pain, run by HaEmek Medical Center, Israel at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
thrombin generation levels and endogenous thrombin potentials (time frame: 4 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2014.