- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01760031
Longterm Follow-up After Remote Ischemic Preconditioning for Prevention of Contrast-induced Nephropathy (RenProLong)
December 28, 2012 updated by: Dr. Fikret Er, University of Cologne
Remote Preconditioning for Contrast-Induced Acute Kidney Injury: Long-Term Follow up (RenPro Longterm)
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Data of the RenPro Trial has been already published.
In the present study data of longterm follow up are collected.
Study Type
Observational
Enrollment (Anticipated)
81
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
NRW
-
Cologne, NRW, Germany, 50937
- University of Cologne
-
-
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 to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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)
Description
All patients who participated to the RenPro trial
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 |
|---|---|
|
Subjects with impaired renal function
Subjects with baseline impaired renal function undergoing cardiac catheterization with contrast-medium exposure
|
Subjects received ischemic preconditioning previous to cardiac catheterization
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
MACCE
Time Frame: 1 Year
|
Major Adverse Cardiac and Cerebrovascular Events (Combined primary endpoint): All-cause mortality, cardiovascular mortality, rehospitalization, stroke, myocardial infarction, hemodialysis |
1 Year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Renal function
Time Frame: 1 year
|
changes of serum creatinine, eGFR, NGAL and cystatin C compared to baseline in both groups.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Fikret Er, MD, University Hospital of Cologne
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
July 1, 2012
Primary Completion (Actual)
December 1, 2012
Study Completion (Anticipated)
January 1, 2013
Study Registration Dates
First Submitted
December 28, 2012
First Submitted That Met QC Criteria
December 28, 2012
First Posted (Estimate)
January 3, 2013
Study Record Updates
Last Update Posted (Estimate)
January 3, 2013
Last Update Submitted That Met QC Criteria
December 28, 2012
Last Verified
December 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RenPro1L
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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