Angiotensin Converting Enzyme Inhibitors & Contrast Induced Nephropathy in Patients Receiving a Cardiac Catheterization
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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" |
- 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 ]
- 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 |
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| Canada, Ontario | |
| Hamilton General Hospital | |
| Hamilton, Ontario, Canada, L8L 2X2 | |
| 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 May 23, 2013