Angiotensin Converting Enzyme Inhibitors & Contrast Induced Nephropathy in Patients Receiving a Cardiac Catheterization

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Shamir Mehta, McMaster University
ClinicalTrials.gov Identifier:
NCT00317252
First received: April 20, 2006
Last updated: October 19, 2012
Last verified: October 2012

April 20, 2006
October 19, 2012
July 2006
March 2012   (final data collection date for primary outcome measure)
Contrast induced nephropathy (creatinine rise of 44umol/L or 25% compared to the pre-randomization creatinine level) at 48-96hrs [ Time Frame: 48 - 96 hours post-cardiac catheterization ] [ Designated as safety issue: No ]
Contrast induced nephropathy (creatinine rise of 44umol/L or 25% compared to baseline) at 48-96hrs
Complete list of historical versions of study NCT00317252 on ClinicalTrials.gov Archive Site
  • Change in serum creatinine at 48-96hrs [ Time Frame: 48 - 96 hours post-cardiac catheterization ] [ Designated as safety issue: No ]
  • Change in creatinine clearance at 48-96hrs [ Time Frame: 48 - 96 hours post-cardiac catheterization ] [ Designated as safety issue: No ]
  • Death, Myocardial Infarction, Stroke, Congestive Heart Failure, dialysis, major bleeding, minor bleeding, hypertension, re-hospitalization at 48-96hrs. [ Time Frame: 48 - 96 hours post-cardiac catheterization ] [ Designated as safety issue: Yes ]
  • Change in serum creatinine at 48-96hrs
  • Change in creatinine clearance at 48-96hrs
  • Death, Myocardial Infarction, Stroke, Congestive Heart Failure, dialysis, major bleeding, minor bleeding, hypertension, re-hospitalization at 48-96hrs.
Not Provided
Not Provided
 
Angiotensin Converting Enzyme Inhibitors & Contrast Induced Nephropathy in Patients Receiving a Cardiac Catheterization
Angiotensin Converting Enzyme Inhibitors and Contrast Induced Nephropathy in Patients Receiving a Cardiac Catheterization "The CAPTAIN Trial"

The purpose of this study is to determine if patients should stop taking their angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) around the time of their angiogram in order to prevent contrast induced nephropathy (CIN).

There are approximately 4000 coronary angiograms performed annually at the Hamilton General Hospital to diagnose and treat coronary artery disease. Many of the patients undergoing this procedure have mild kidney disease. Exposure to the contrast dye used in the procedure puts them at risk of worsening kidney function, a condition called contrast induced nephropathy (CIN) which is associated with significant morbidity and mortality. Many of these patients are also on an antihypertensive drug called an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB). Their effects on the kidney during contrast exposure are not known. Our understanding of how the drug works leads us to believe that the use of these drugs around the time of contrast exposure may have detrimental effects on the kidney.

The purpose of this study is to determine if patients should continue taking or stop taking their ACE inhibitor or ARB around the time of their angiogram in order to prevent CIN.

Patients undergoing an elective coronary angiogram with mild kidney disease and currently taking an ACE inhibitor or ARB will be randomly divided into two groups. One group will continue taking their ACE inhibitor or ARB while the other group will stop taking their ACE inhibitor or ARB for at least 24 hours before and will resume their ACE inhibitor or ARB 48 to 96 hours after their angiogram. In both groups, kidney function will be assessed by means of a simple blood test both before and 48 to 96 hours after the angiogram. By doing this, we can determine which group had more kidney damage and which group had less kidney damage from the contrast exposure. We suspect that patients who do not take their ACE inhibitor around the time of their angiogram will have less kidney damage. All patients will receive the accepted measures for preventing kidney disease from contrast dye exposure.

CIN is associated with significant morbidity and mortality. If the use of ACEIs during coronary angiograms are associated with an increased risk of CIN, then these patients may benefit from holding their ACEI around the time of their procedure potentially improving their outcomes. This is a low cost intervention that could potentially change practice, reduce morbidity, save lives and pave the way for larger clinical trials.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Kidney Failure
Drug: Hold ACEI or ARB
Angiotensin converting enzyme inhibitor or angiotensin receptor blocker held at least 24 hours pre-cardiac catheterization and restarted 48-96 hours post-catheterization (after creatinine measurement)
Other Name: Includes all ACE inhibitors or ARBs
  • Experimental: Hold ACEI or ARB
    Angiotensin converting enzyme inhibitor or angiotensin receptor blocker held >= 24 hours pre-cardiac catheterization and restarted post-catheterization after creatinine measurement (48-96 hours post)
    Intervention: Drug: Hold ACEI or ARB
  • Continue ACE1 or ARB
    Randomized to continue on prescribed ACE1 or ARB
    Intervention: Drug: Hold ACEI or ARB
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
220
March 2012
March 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Scheduled for Angiography in >= 24hrs from enrolment
  • Documented Cr >= 150 within 3 months before cardiac catheterization AND/OR documented Cr >= 132umol/L within 1 week Before Cardiac Catheterization
  • Currently Taking an ACE Inhibitor

Exclusion Criteria:

  • Patients with end stage renal disease (for example, patient on dialysis)
  • Emergency Cardiac Catheterization with insufficient time to hold the ACEI
  • Acute Pulmonary Edema
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00317252
06-005
No
Dr. Shamir Mehta, McMaster University
Hamilton Health Sciences Corporation
Not Provided
Principal Investigator: Shamir R Mehta, MD MSc McMaster University
McMaster University
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP