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
  Purpose

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 Intervention Phase
Kidney Failure
Drug: Hold ACEI or ARB
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Angiotensin Converting Enzyme Inhibitors and Contrast Induced Nephropathy in Patients Receiving a Cardiac Catheterization "The CAPTAIN Trial"

Further study details as provided by McMaster University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 220
Study Start Date: July 2006
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr. Shamir Mehta, Associate Professor of Medicine, McMaster University
ClinicalTrials.gov Identifier: NCT00317252     History of Changes
Other Study ID Numbers: 06-005
Study First Received: April 20, 2006
Last Updated: October 19, 2012
Health Authority: Canada: Health Canada

Keywords provided by 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
Angiotensin-Converting Enzyme Inhibitors
Enzyme Inhibitors
Angiotensin Receptor Antagonists
Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014