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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dr. Fikret Er, University of Cologne
ClinicalTrials.gov Identifier:
NCT01760031
First received: December 28, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  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)

Further study details as provided by University of Cologne:

Primary Outcome Measures:
  • MACCE [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: December 28, 2012
Last Updated: December 28, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by University of Cologne:
preconditioning
contrast-induced acute kidney injury
renal faliure

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

ClinicalTrials.gov processed this record on August 28, 2014