Platelets Function and Cardiovascular Events in Patients With End Stage Renal Disease
Recruitment status was Recruiting
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Purpose
The purpose of this study is to perform a prospective evaluation regarding the relationship between platelets function and cardiovascular events in patients with ESRD.
The study will include 100-200 patients with ESRD, age 18 years or older, treated in the nephrology division of Assaf Harofeh medical center.
The primary end points of the study are cardiovascular events including acute myocardial infarction (defined as symptoms + acute elevation of TnI), need for coronary artery disease revascularization, or acute cerebrovascular event (TIA or CVA) and mortality. The secondary end points are any hospitalization due to acute coronary syndrome, active bleeding with the need for blood transfusion and dialysis access graft thrombosis (time to thrombosis).
Blood will be taken for complete blood count including platelets count and mean platelets volume, serum electrolytes, albumin, blood lipids, Kt/V, troponin and two 5 ml aliquots from each blood collection will be separated and stored at -70co until analyzed for oxidative stress, homocysteine and highly sensitive CRP will be performed. Five mL of blood will be sent for platelets function assessment.
During the follow up period the correlation between platelets function an cardiovascular events will be assessed.
| Condition | Intervention |
|---|---|
|
End Stage Renal Disease Cardiovascular Disease |
Procedure: Blood Sample |
| Study Type: | Observational |
| Study Design: | Observational Model: Defined Population Time Perspective: Longitudinal Time Perspective: Prospective |
| Estimated Enrollment: | 150 |
| Study Start Date: | September 2006 |
| Estimated Study Completion Date: | December 2007 |
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- The study will include patients with end stage renal disease, age 18 years or older, treated in the nephrology division of Assaf Harofeh medical center.
Exclusion Criteria:
- Patients will be excluded if their platelets count will be lower then 50,000 cu/mm, if they have known hematologic malignancies, other solid malignancy with life expectancy of less then 1 year or if they are treated with Warfarin (Comadin).
Contacts and Locations| Contact: Shai Efrati, MD | +972-577-346364 | efratishai@013.net |
| Israel | |
| Nephrology Division, Aassaf-Harofeh Medical Center | Recruiting |
| Zerifin, Israel, 70300 | |
| Contact: Shai Efrati, MD +972-577-346364 efratishai@013.net | |
| Principal Investigator: Mark Katz, MD | |
| Study Chair: | Shai Efrati, MD | Assaf-Harofeh Medical Center |
| Principal Investigator: | Mark Katz, MD | Assaf-Harofeh Medical Center |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00407368 History of Changes |
| Other Study ID Numbers: | 75/06 |
| Study First Received: | December 4, 2006 |
| Last Updated: | December 4, 2006 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Kidney Diseases Kidney Failure, Chronic |
Urologic Diseases Renal Insufficiency, Chronic Renal Insufficiency |
ClinicalTrials.gov processed this record on May 23, 2013