NCT00390585

Brief Summary

The purpose of this study is to demonstrate that Iodixanol 320 is associated with a lower incidence of contrast-induced nephropathy (CIN) when compared with hyperosmolar contrast medium Iomeprol 350 in patients with impaired renal function undergoing percutaneous coronary interventions (PCI).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
324

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2006

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 20, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

March 15, 2010

Status Verified

February 1, 2008

Enrollment Period

1.5 years

First QC Date

October 19, 2006

Last Update Submit

March 12, 2010

Conditions

Renal Insufficiency, ChronicAngioplasty, Transluminal, Percutaneous CoronaryCoronary Arteriosclerosis

Keywords

Renal InsufficiencyAngioplasty, Transluminal, Percutaneous CoronaryContrast media

Outcome Measures

Primary Outcomes (1)

  • Contrast-induced nephropathy after percutaneous coronary intervention during primary hospitalization

    primary hospitalization

Secondary Outcomes (4)

  • Duration of primary hospitalization

    Duration of primary hospitalization

  • Incidence of severe acute kidney failure

    severe acute kidney failure

  • Contrast-induced nephropathy six months after PCI

    6 months

  • Mortality and myocardial infarction at 6 and 12 months

    6 and 12 months

Study Arms (2)

A

EXPERIMENTAL

Iodixanol 320

Drug: Iodixanol 320

B

ACTIVE COMPARATOR

Iomeprol 350

Drug: Iomeprol 350

Interventions

Iodixanol 320DRUG

Iodixanol 320 is used as contrast media while coronary intervention.

Also known as: VISIPAQUE (TM)
A
Iomeprol 350DRUG

Iomeprol 350 is used as contrast media while coronary intervention.

Also known as: Imeron
B

Eligibility Criteria

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

You may qualify if:

  • chronic renal failure
  • Informed, written consent

You may not qualify if:

  • Cardiogenic shock
  • Dialysis
  • kidney transplantation
  • Concurrent intake of nephrotoxic medication
  • Planned or proceeded parenteral (i.v. or i.a.) administration of iodine-containing contrast medium at least 7 days before/after catheterization.
  • Contra-indications for the use of Iodixanol (e.g. allergies)
  • Women who are known to be pregnant, who are of childbearing potential and test positive for pregnancy, who have given birth within the last 90 days, who are breastfeeding
  • Patient's inability to fully cooperate with the study protocol.
  • Previous enrollment in this trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Deutsches Herzzentrum Muenchen

Munich, 80636, Germany

Location

1. Medizinische Klinik, Klinikum rechts der Isar

München, 81675, Germany

Location

Related Publications (3)

  • Levey AS, Bosch JP, Lewis JB, Greene T, Rogers N, Roth D. A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Modification of Diet in Renal Disease Study Group. Ann Intern Med. 1999 Mar 16;130(6):461-70. doi: 10.7326/0003-4819-130-6-199903160-00002.

    PMID: 10075613BACKGROUND

  • Alberti KG, Zimmet PZ. Definition, diagnosis and classification of diabetes mellitus and its complications. Part 1: diagnosis and classification of diabetes mellitus provisional report of a WHO consultation. Diabet Med. 1998 Jul;15(7):539-53. doi: 10.1002/(SICI)1096-9136(199807)15:73.0.CO;2-S.

    PMID: 9686693BACKGROUND

  • Wessely R, Koppara T, Bradaric C, Vorpahl M, Braun S, Schulz S, Mehilli J, Schomig A, Kastrati A; Contrast Media and Nephrotoxicity Following Coronary Revascularization by Angioplasty Trial Investigators. Choice of contrast medium in patients with impaired renal function undergoing percutaneous coronary intervention. Circ Cardiovasc Interv. 2009 Oct;2(5):430-7. doi: 10.1161/CIRCINTERVENTIONS.109.874933. Epub 2009 Sep 22.

    PMID: 20031753RESULT

MeSH Terms

Conditions

Renal Insufficiency, ChronicCoronary Artery DiseaseRenal Insufficiency

Interventions

iodixanoliomeprol

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Albert Schoemig, MD

    Deutsches Herzzentrum Muenchen

    STUDY CHAIR

  • Rainer Wessely, MD

    Deutsches Herzzentrum Muenchen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 19, 2006

First Posted

October 20, 2006

Study Start

July 1, 2006

Primary Completion

January 1, 2008

Study Completion

December 1, 2008

Last Updated

March 15, 2010

Record last verified: 2008-02

Locations

DE(2)