- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01064674
Cardiovascular Evaluation Before Renal Transplantation
February 5, 2010 updated by: University Hospital Muenster
Cardiovascular Diagnostic Before Renal Transplantation: a Prospective Study to Assess Cardiovascular Morbidity Before Renal Transplantation and to Improve Standard Diagnostic Procedures.
Due to rising importance of cardiovascular disease before and after renal transplantation we have changed our standard diagnostic procedure and perform stress echocardiography and myocardial scintigraphy.
We would like to monitor these results and the outcome of our patients.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Chronic kidney disease is a well-known risk factor for cardiovascular disease.
Patients waiting for a renal transplantation usually undergo an extensive diagnostic procedure to avoid complications after transplantation such as neoplasia or inflammation.
In the past years, cardiovascular complications before and after renal transplantation have gained more attention.
We therefore have changed our standard diagnostic procedure before renal transplantation and perform stress echocardiography and myocardial scintigraphy.
Thus we would like to evaluate our new standard diagnostic procedure and observe the results of these diagnostic procedures as well as their impact on clinical outcome.
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Barbara Suwelack, MD
- Phone Number: 00492518347540
- Email: barbara.suwelack@ukmuenster.de
Study Contact Backup
- Name: Viola Malyar, MD
- Phone Number: 00492518347540
- Email: viola.malyar@ukmuenster.de
Study Locations
-
-
-
Muenster, Germany, 48149
- Recruiting
- Department of Internal Medicine D, University Hospital Muenster
-
Contact:
- Barbara Suwelack, MD
- Phone Number: 00492518347540
- Email: barbara.suwelack@ukmuenster.de
-
Contact:
- Viola Malyar, MD
- Phone Number: 00492518347540
- Email: viola.malyar@ukmuenster.de
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All patients with endstage renal disease which are awaiting their ergsitration to our transplantation programm since July 2009 until July 2010.
Description
Inclusion Criteria:
- endstage renal disease
- preparing for renal transplantation
Exclusion Criteria:
- children (< 18 years)
- women who are pregnant or nursing
- patients who are also awaiting heart transplantation or have already a heart transplant
- severe mental illness
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
before renal transplantation
Patients with CKD IV° to V° who are actually registering for a renal transplantation in our department.
|
Cardiovascular diagnostic standard procedure before renal transplantation using stress echocardiography and stress myocardial scintigraphy.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
cardiovascular morbidity
Time Frame: one year
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Barbara Suwelack, MD, University Hospital Muenster
- Study Chair: Hermann Pavenstädt, MD, University Hospital Muenster
- Study Chair: Holger Reinecke, MD, University Hospital Muenster
- Study Chair: Otmar Schober, MD, PhD, University Hospital Muenster
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2009
Primary Completion (Anticipated)
June 1, 2010
Study Completion (Anticipated)
September 1, 2010
Study Registration Dates
First Submitted
February 5, 2010
First Submitted That Met QC Criteria
February 5, 2010
First Posted (Estimate)
February 8, 2010
Study Record Updates
Last Update Posted (Estimate)
February 8, 2010
Last Update Submitted That Met QC Criteria
February 5, 2010
Last Verified
January 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KVDiagnostikpratransplantation
- HerzundNierenMünster (Registry Identifier: clinical trials registry.)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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