|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Hamilton Health Sciences Corporation |
|---|---|
| Information provided by (Responsible Party): | Dr. Shamir Mehta, McMaster University |
| ClinicalTrials.gov Identifier: | NCT00317252 |
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 II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group 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" |
| Estimated Enrollment: | 200 |
| Study Start Date: | July 2006 |
| Estimated Study Completion Date: | February 2012 |
| Estimated Primary Completion Date: | January 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
|
|
No Intervention: Continue ACEI or ARB
Angiotensin converting enzyme inhibitor or angiotensin receptor blocker continued
|
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
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Shamir R Mehta, MSc MD | 905-527-4322 ext 40631 | smehta@mcmaster.ca |
| Contact: Shamir R Mehta, MSc MD | 905-521-2631 | smehta@mcmaster.ca |
| Canada, Ontario | |
| Hamilton General Hospital | Recruiting |
| Hamilton, Ontario, Canada, L8L 2X2 | |
| Principal Investigator: Shamir R Mehta, MD MSc | |
| Principal Investigator: | Shamir R Mehta, MD MSc | McMaster University |
More Information
| 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: | December 7, 2011 |
| Health Authority: | Canada: Health Canada |
|
contrast induced nephropathy contrast nephropathy contrast media kidney diseases angiotensin converting enzyme inhibitors |
|
Kidney Diseases Renal Insufficiency Urologic Diseases Angiotensin-Converting Enzyme Inhibitors Enzyme Inhibitors |
Angiotensin Receptor Antagonists Protease Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |