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

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ClinicalTrials.gov Identifier: NCT00317252
Recruitment Status : Completed
First Posted : April 24, 2006
Last Update Posted : October 22, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Kidney Failure Drug: Hold ACEI or ARB Phase 2

Detailed Description:

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Angiotensin Converting Enzyme Inhibitors and Contrast Induced Nephropathy in Patients Receiving a Cardiac Catheterization "The CAPTAIN Trial"
Study Start Date : July 2006
Primary Completion Date : March 2012
Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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)
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
Continue ACE1 or ARB
Randomized to continue on prescribed ACE1 or ARB
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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Change in serum creatinine at 48-96hrs [ Time Frame: 48 - 96 hours post-cardiac catheterization ]
  2. Change in creatinine clearance at 48-96hrs [ Time Frame: 48 - 96 hours post-cardiac catheterization ]
  3. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00317252


Locations
Canada, Ontario
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Investigators
Principal Investigator: Shamir R Mehta, MD MSc McMaster University
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Shamir Mehta, Associate Professor of Medicine, McMaster University
ClinicalTrials.gov Identifier: NCT00317252     History of Changes
Other Study ID Numbers: 06-005
First Posted: April 24, 2006    Key Record Dates
Last Update Posted: October 22, 2012
Last Verified: October 2012

Keywords provided by Dr. Shamir Mehta, McMaster University:
contrast induced nephropathy
contrast nephropathy
contrast media
kidney diseases
angiotensin converting enzyme inhibitors

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency
Urologic Diseases
Enzyme Inhibitors
Angiotensin-Converting Enzyme Inhibitors
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Protease Inhibitors