NCT05906758

Brief Summary

The aim of this study is to evaluate the safety of ultra-low contrast coronary angiography in patients with pre-existing acute kidney injury.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at below P25 for phase_3

Timeline
7mo left

Started Sep 2025

Shorter than P25 for phase_3

Geographic Reach
1 country

2 active sites

Status
recruiting

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 Progress54%
Sep 2025Dec 2026

First Submitted

Initial submission to the registry

June 7, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
2.2 years until next milestone

Study Start

First participant enrolled

September 5, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

September 23, 2025

Status Verified

September 1, 2025

Enrollment Period

1.2 years

First QC Date

June 7, 2023

Last Update Submit

September 17, 2025

Conditions

Acute Kidney Injury

Keywords

Coronary angiographyUltra low contrast

Outcome Measures

Primary Outcomes (1)

  • Change in incidence of Contrast Induced Nephropathy (CIN)

    CIN is defined as an increase in serum creatinine by 0.5mg/dl or a relative rise of 25% from the baseline value. The investigators will measure the incidence of CIN by the increase in serum creatinine to see if the incidence will be the same in both arms whether the patient received the immediate angiography or if it was delayed until kidney function has been stabilized.

    Within 7 days

Secondary Outcomes (2)

  • Incidence of earlier occurrence of CIN

    Within 7 days

  • Incidence of renal replacement therapy at up to 7 days post-angiography

    Within 7 days

Study Arms (2)

Immediate intervention arm

ACTIVE COMPARATOR

Immediate angiography will be performed within 24 hours of enrollment. Omnipaque contrast will be administered. Serum creatinine will be collected on enrollment, within 6 hours before coronary angiography, and at 24h, 48h and 1-week after the angiography, as expected in common practice. Pre- and post-hydration administration will be at the discretion of the treating physician. In case percutaneous coronary intervention is indicated it will be schedule for 7 days after angiography.

Procedure: Angiography

Delayed intervention arm

PLACEBO COMPARATOR

Delayed angiography will be performed after kidney function stabilizes.

Procedure: Angiography

Interventions

AngiographyPROCEDURE

Coronary angiography with less than 20cc of contrast materials

Delayed intervention armImmediate intervention arm

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hospitalized patients who have AKI at admission or who develop AKI during admission and require invasive coronary angiography will be included in the trial.

You may not qualify if:

  • Stabilized renal function manifested by unchanged or downtrending serum creatinine during a 24-hour period prior to enrollment.
  • Contraindication for invasive coronary angiography other than AKI.
  • Percutaneous coronary intervention is indicated and cannot be postponed by 7 days.
  • Need for renal replacement therapy before coronary angiography or planned renal replacement therapy after coronary angiography (if premeditated before coronary angiography).
  • Administration of intravascular contrast media during 7 days prior to the coronary angiography or within 6 days after coronary angiography.
  • Pregnant patients, prisoners, cognitively impaired subjects, age below 18 years, unable or unwilling to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tulane University Medical Center

New Orleans, Louisiana, 70112, United States

RECRUITING

University Medical Center

New Orleans, Louisiana, 70112, United States

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Cerebral Angiography

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

NeuroradiographyNeuroimagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisAngiographyRadiographyDiagnostic Techniques, CardiovascularDiagnostic Techniques, NeurologicalInvestigative Techniques

Study Officials

  • Zach Rozenbaum, MD

    Tulane University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zach Rozenbaum, MD

CONTACT

504-988-5493zrozenbaum@tulane.edu

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2023

First Posted

June 18, 2023

Study Start

September 5, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

September 23, 2025

Record last verified: 2025-09

Locations

US(2)