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Cardiovascular Evaluation Before Renal Transplantation

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ClinicalTrials.gov Identifier: NCT01064674
Recruitment Status : Unknown
Verified January 2010 by University Hospital Muenster.
Recruitment status was:  Recruiting
First Posted : February 8, 2010
Last Update Posted : February 8, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Chronic Kidney Disease Coronary Artery Disease Other: diagnostic procedure

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 Design

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cardiovascular Diagnostic Before Renal Transplantation: a Prospective Study to Assess Cardiovascular Morbidity Before Renal Transplantation and to Improve Standard Diagnostic Procedures.
Study Start Date : December 2009
Estimated Primary Completion Date : June 2010
Estimated Study Completion Date : September 2010

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U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
before renal transplantation
Patients with CKD IV° to V° who are actually registering for a renal transplantation in our department.
Other: diagnostic procedure
Cardiovascular diagnostic standard procedure before renal transplantation using stress echocardiography and stress myocardial scintigraphy.
Other Name: diagnostic standard procedure


Outcome Measures

Primary Outcome Measures :
  1. cardiovascular morbidity [ Time Frame: one year ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01064674


Contacts
Contact: Barbara Suwelack, MD 00492518347540 barbara.suwelack@ukmuenster.de
Contact: Viola Malyar, MD 00492518347540 viola.malyar@ukmuenster.de

Locations
Germany
Department of Internal Medicine D, University Hospital Muenster Recruiting
Muenster, Germany, 48149
Contact: Barbara Suwelack, MD    00492518347540    barbara.suwelack@ukmuenster.de   
Contact: Viola Malyar, MD    00492518347540    viola.malyar@ukmuenster.de   
Sponsors and Collaborators
University Hospital Muenster
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
More Information

Responsible Party: PD Dr. med. Barbara Suwelack, Internal Medicine D, University Hospital of Muenster
ClinicalTrials.gov Identifier: NCT01064674     History of Changes
Other Study ID Numbers: KVDiagnostikpratransplantation
HerzundNierenMünster ( Registry Identifier: clinical trials registry. )
First Posted: February 8, 2010    Key Record Dates
Last Update Posted: February 8, 2010
Last Verified: January 2010

Keywords provided by University Hospital Muenster:
renal transplantation
cardiovascular morbidity
evaluation before renal transplantation

Additional relevant MeSH terms:
Kidney Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Renal Insufficiency, Chronic
Urologic Diseases
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Renal Insufficiency