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

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ClinicalTrials.gov Identifier: NCT01760031
Recruitment Status : Unknown
Verified December 2012 by Dr. Fikret Er, University of Cologne.
Recruitment status was:  Active, not recruiting
First Posted : January 3, 2013
Last Update Posted : January 3, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Impaired Renal Function Other: Ischemic preconditioning

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

Study Design

Study Type : Observational
Estimated Enrollment : 81 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Remote Preconditioning for Contrast-Induced Acute Kidney Injury: Long-Term Follow up (RenPro Longterm)
Study Start Date : July 2012
Primary Completion Date : December 2012
Estimated Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Tests
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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


Outcome Measures

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


Eligibility Criteria

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 Posted: January 3, 2013    Key Record Dates
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