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Longterm Follow-up After Remote Ischemic Preconditioning for Prevention of Contrast-induced Nephropathy (RenProLong)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2012 by Dr. Fikret Er, University of Cologne.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01760031
First Posted: January 3, 2013
Last Update Posted: January 3, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Fikret Er, University of Cologne
  Purpose
Remote ischemic preconditioning reduces the incidence of contrast-induced acute kidney injury in patients undergoing elective coronary angiography. This study was designed to acquire long-term data of initially randomized patients in the RenPro Trial.

Condition Intervention
Impaired Renal Function Other: Ischemic preconditioning

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Remote Preconditioning for Contrast-Induced Acute Kidney Injury: Long-Term Follow up (RenPro Longterm)

Resource links provided by NLM:


Further study details as provided by Dr. Fikret Er, University of Cologne:

Primary Outcome Measures:
  • MACCE [ Time Frame: 1 Year ]

    Major Adverse Cardiac and Cerebrovascular Events (Combined primary endpoint):

    All-cause mortality, cardiovascular mortality, rehospitalization, stroke, myocardial infarction, hemodialysis



Secondary Outcome Measures:
  • Renal function [ Time Frame: 1 year ]
    changes of serum creatinine, eGFR, NGAL and cystatin C compared to baseline in both groups.


Estimated Enrollment: 81
Study Start Date: July 2012
Estimated Study Completion Date: January 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Subjects with impaired renal function
Subjects with baseline impaired renal function undergoing cardiac catheterization with contrast-medium exposure
Other: Ischemic preconditioning
Subjects received ischemic preconditioning previous to cardiac catheterization

Detailed Description:
Data of the RenPro Trial has been already published. In the present study data of longterm follow up are collected.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients refered for elective cardiac catherization to the university hospital of Cologne. All patients who participated to the RenPro trial (www.germanctr.de; DRKS-ID DRKS00000666)
Criteria
All patients who participated to the RenPro trial
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01760031


Locations
Germany
University of Cologne
Cologne, NRW, Germany, 50937
Sponsors and Collaborators
University of Cologne
Investigators
Principal Investigator: Fikret Er, MD University Hospital of Cologne
  More Information

Publications:
Responsible Party: Dr. Fikret Er, Assistant Professor, University of Cologne
ClinicalTrials.gov Identifier: NCT01760031     History of Changes
Other Study ID Numbers: RenPro1L
First Submitted: December 28, 2012
First Posted: January 3, 2013
Last Update Posted: January 3, 2013
Last Verified: December 2012

Keywords provided by Dr. Fikret Er, University of Cologne:
preconditioning
contrast-induced acute kidney injury
renal faliure

Additional relevant MeSH terms:
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases