NCT01760031

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
81

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

December 28, 2012

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 3, 2013

Completed
Last Updated

January 3, 2013

Status Verified

December 1, 2012

Enrollment Period

5 months

First QC Date

December 28, 2012

Last Update Submit

December 28, 2012

Conditions

Keywords

preconditioningcontrast-induced acute kidney injuryrenal faliure

Outcome Measures

Primary Outcomes (1)

  • MACCE

    Major Adverse Cardiac and Cerebrovascular Events (Combined primary endpoint): All-cause mortality, cardiovascular mortality, rehospitalization, stroke, myocardial infarction, hemodialysis

    1 Year

Secondary Outcomes (1)

  • Renal function

    1 year

Study Arms (1)

Subjects with impaired renal function

Subjects with baseline impaired renal function undergoing cardiac catheterization with contrast-medium exposure

Other: Ischemic preconditioning

Interventions

Subjects received ischemic preconditioning previous to cardiac catheterization

Subjects with impaired renal function

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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)

All patients who participated to the RenPro trial

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Cologne

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Related Publications (1)

  • Er F, Nia AM, Dopp H, Hellmich M, Dahlem KM, Caglayan E, Kubacki T, Benzing T, Erdmann E, Burst V, Gassanov N. Ischemic preconditioning for prevention of contrast medium-induced nephropathy: randomized pilot RenPro Trial (Renal Protection Trial). Circulation. 2012 Jul 17;126(3):296-303. doi: 10.1161/CIRCULATIONAHA.112.096370. Epub 2012 Jun 26.

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Ischemic Preconditioning

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsInvestigative Techniques

Study Officials

  • Fikret Er, MD

    University Hospital of Cologne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 28, 2012

First Posted

January 3, 2013

Study Start

July 1, 2012

Primary Completion

December 1, 2012

Study Completion

January 1, 2013

Last Updated

January 3, 2013

Record last verified: 2012-12

Locations