NCT02991742

Brief Summary

Contrast media-induced nephropathy following diagnostic and therapeutic cardiac catheterization.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,262

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2016

Longer than P75 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

December 1, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 13, 2016

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

December 14, 2016

Status Verified

December 1, 2016

Enrollment Period

Same day

First QC Date

December 1, 2016

Last Update Submit

December 12, 2016

Conditions

Keywords

nephropathycatheterizationcontrast mediaioxaglateiodixanolhigh riskprevention

Outcome Measures

Primary Outcomes (1)

  • Contrast-induced nephropathy incidence

    Between 48 and 96 hours after diagnostic and therapeutic cardiac catheterization

Secondary Outcomes (2)

  • Composite of death or need for dialysis in 48 to 96 hours and at 30 days after diagnostic and therapeutic cardiac catheterization

    30 days

  • The individual components of the combined outcome (total mortality or dialysis indication)

    30 days

Study Arms (2)

Iodixanol

Iodixanol contrast media

Other: contrast media

Ioxaglate

Ioxaglate contrast media

Other: contrast media

Interventions

Compare 2 contrast media

Also known as: Iodixanol X Ioxaglate
IodixanolIoxaglate

Eligibility Criteria

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

Patients undergoing coronary angiography or percutaneous interventions will be eligible for the trial if they have at least 1 risk factor for contrast-induced acute kidney injury

You may qualify if:

  • At least one of the following criteria
  • Aged more than 70 years-old
  • Chronic renal failure
  • Diabetes mellitus
  • Congestive heart failure - left ventricular ejection fraction \< 0.50
  • Shock or intra-aortic ballon pump use
  • Urgency or emergency procedures

You may not qualify if:

  • Patients in dialysis
  • Allergy to iodine
  • Patient refusal to informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Freitas RAP, Tanajura LF, Mehran R, Chamie D, Chaves A, Centemero M, Braga S, Costa R, Cao D, Sousa A, Feres F, Costa JR Jr. Ioxaglate Versus IoDixanol for the Prevention of Contrast-Induced Nephropathy: The IDPC Trial. J Invasive Cardiol. 2023 Jun;35(6):E281-E290. doi: 10.25270/jic/21.00249. Epub 2023 May 16.

MeSH Terms

Conditions

Acute Kidney InjuryKidney Diseases

Interventions

Contrast Media

Condition Hierarchy (Ancestors)

Renal InsufficiencyUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Uses of ChemicalsPharmacologic ActionsChemical Actions and UsesSpecialty Uses of Chemicals

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 1, 2016

First Posted

December 13, 2016

Study Start

December 1, 2016

Primary Completion

December 1, 2016

Study Completion

November 1, 2020

Last Updated

December 14, 2016

Record last verified: 2016-12