RECOVER:Comparison of Renal Toxicity Between Visipaque(Iodixanol)and Hexabrix(Ioxaglate)in Renal Insufficiency Undergoing Coronary Angiography

NCT00247325 | Completed Phase 4

• 1 other identifier: 144-가-24
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

In the treatment of coronary heart disease which is the major cause of heart attack, direct mechanical treatment with catheters such as the coronary angiography,coronary balloon intervention and stenting intervention are the mainstay of therapy in recent years. In that procedures, we should use the contrast media, and it may cause kidney toxicity especially in the patients with underlying kidney disease and decreased kidney function. We intended to find out which contrast agent has less kidney toxicity in the catheter based treatment of coronary arterial diseases in patients with underlying decreased kidney function

Conditions

Kidney Failure

Keywords

Kidney failure; Contrast media; Iodixanol; Ioxaglate

Outcome Measures

Primary Outcomes (1)

• Incidence of contrast induced nephropathy, defined as either a relative increase in serum creatinine from baseline of >=25% or an absolute increase of >=0.5mg/dL(44.2µmol/L) during days 1 and 2

Secondary Outcomes (1)

• proportion of patients exhibiting an increase in serum creatinine of >=0.5mg/dL(44.2µmol/L), the proportion with a >=1.0 mg/dL(88.4µmol/L) increase in serum creatinine, and the mean peak increase in serum creatinine

Interventions

Iodixanol(Drug) DRUG

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• creatinine clearance rates ≤60 mL/min using the Cockcroft-Gault formula
• Patients who undergo coronary catheterization
• Age of 19 or over 19.

You may not qualify if:

• pregnancy
• lactation
• having received contrast media within 7 days of study entry
• emergent coronary angiography
• acute renal failure
• end-stage renal disease requiring dialysis
• history of hypersensitivity reaction to contrast media
• cardiogenic shock
• pulmonary edema
• multiple myeloma
• mechanical ventilation
• parenteral use of diuretics
• use of N-acetylcysteine
• use of metformin or nonsteroidal anti-inflammatory drugs within 48 hours of the procedure.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital , Cardiovascular Center

Seoul, South Korea

Location

Related Publications (1)

• Jo SH, Youn TJ, Koo BK, Park JS, Kang HJ, Cho YS, Chung WY, Joo GW, Chae IH, Choi DJ, Oh BH, Lee MM, Park YB, Kim HS. Renal toxicity evaluation and comparison between visipaque (iodixanol) and hexabrix (ioxaglate) in patients with renal insufficiency undergoing coronary angiography: the RECOVER study: a randomized controlled trial. J Am Coll Cardiol. 2006 Sep 5;48(5):924-30. doi: 10.1016/j.jacc.2006.06.047. Epub 2006 Aug 17.

  PMID: 16949481 RESULT

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Hyo-Soo Kim, M.D., Ph.D.

  Seoul National University Hospital, Cardiovascular Center

  STUDY DIRECTOR

• Byung-Hee Oh, M.D., Ph.D.

  Seoul National University Hospital, Internal Medicine/ Cardiovascular Center

  STUDY CHAIR

• Sang-Ho Jo, M.D.

  Seoul National University Hospital, Cardiovascular Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 31, 2005
• First Posted: November 1, 2005
• Study Start: January 1, 2004
• Study Completion: December 1, 2004
• Last Updated: November 30, 2006

Record last verified: 2005-01

Locations

KR (1)