Who is sponsoring NCT01137786?

NCT01137786 is sponsored by Bracco Diagnostics, Inc.

What drugs are being tested in NCT01137786?

Interventions in NCT01137786: Non ionic contrast media comparator, Non ionic contrast media comparator.

What condition does NCT01137786 study?

NCT01137786 studies Coronary Artery Stenosis.

Is NCT01137786 still recruiting?

NCT01137786 is currently completed. Last updated 7 August 2013.

Are results published for NCT01137786?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2013-08-07 · How we verify

NCT01137786

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase IV Pilot Study to Evaluate Kidney Damage Measured by Neutrophil Gelatinase-Associated Lipocalin (NGAL) as a New Bio-Marker in Patients With Normal eGFR Undergoing Percutaneous Coronary Intervention With IOPAMIDOL Injection 370 or IODIXANOL 320

Completed Phase 4 Results posted Last updated 7 August 2013

What this trial tests

Phase 4 trial testing Non ionic contrast media comparator in Coronary Artery Stenosis in 49 participants. Completed in 1 April 2012.

Timeline

1 December 2010

Primary endpoint
1 April 2012

1 April 2012

Quick facts

Lead sponsor	Bracco Diagnostics, Inc
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	diagnostic
Enrollment	49
Start date	1 December 2010
Primary completion	1 April 2012
Estimated completion	1 April 2012
Sites	1 location across United States

Drugs / interventions tested

Non ionic contrast media comparator — full drug profile →
Non ionic contrast media comparator — full drug profile →

Conditions studied

Coronary Artery Stenosis — all drugs for Coronary Artery Stenosis →

Sponsor

Bracco Diagnostics, Inc — full company profile →

Who can join

18 and older, any sex, with Coronary Artery Stenosis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic Low Osmolar Contrast Media.
Time frame: Baseline and 2, 4, 6, 24, 48, and 72 hours post-dose
Mean change from baseline values for serum NGAL at 2,4,6,24,48 and 72 hours, and urine NGAL at 2,4,6,24, and 48 hours following the administration of non-ionic low osmolar contrast media.

Sponsor's own description

This is a pilot study, randomized, double-blind, parallel group comparison of two iodinated contrast agents used during percutaneous coronary intervention (PCI). All patients enrolled must have normal eGFR. Statistical summaries will be presented to analyse the various laboratory tests for the two groups.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Coronary Artery Stenosis

Currently open trials in the same condition.

NCT06177743 — IRIS-Coroflex NEO Cohort · recruiting
NCT04893291 — Sirolimus-coated Balloon Versus Drug-eluting Stent in Native Coronary Vessels - TRANSFORM II · NA · active not recruiting
NCT05133843 — Complete Functional Assessment of Intermediate Coronary Artery Stenosis Before and After Transcatheter Aortic Valve Impl · NA · recruiting
NCT04604197 — ANGiographic Evaluation of Left Main Coronary Artery INtErvention · NA · active not recruiting
NCT04192747 — The Elixir Bioadaptor vs. The Onyx Stent in De Novo Native Coronary Arteries · NA · active not recruiting

Other Bracco Diagnostics, Inc trials

Trials by the same sponsor.

NCT06400004 — Lumason® Infusion vs. Bolus Administrations · Phase 3 · recruiting
NCT04453059 — Study With Oral Isovue in Abdominopelvic CT · completed
NCT04248153 — Optimal Timing of BR55 CEUS of the Ovaries · Phase 2 · terminated
NCT03779906 — Thyroid Function of Pediatric Subjects Following Isovue® Administration · Phase 4 · terminated
NCT03493464 — BR55 in Characterization of Ovarian Lesions · Phase 2 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01137786 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bracco Diagnostics, Inc
Last refreshed: 7 August 2013

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01137786.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing