Kidney FailurePhase 2NCT00317252
Angiotensin Converting Enzyme Inhibitors & Contrast Induced Nephropathy in Patients Receiving a Cardiac Catheterization
A Phase 2 study testing Hold ACEI or ARB in people with Kidney Failure, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Kidney Failure
- What is being tested?
- Hold ACEI or ARB
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2006to Mar 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with end stage renal disease (for example, patient on dialysis)
- Emergency Cardiac Catheterization with insufficient time to hold the ACEI
- Acute Pulmonary Edema
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Kidney Failure
- Being tested
- Hold ACEI or ARB
- Keywords
- contrast induced nephropathy, contrast nephropathy, contrast media, kidney diseases, angiotensin converting enzyme inhibitors
- Medical subject headings
- Renal Insufficiency, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hold ACEI or ARBDrug
Also called Includes all ACE inhibitors or ARBs
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)
| Study group | Role | What they receive |
|---|---|---|
| Hold ACEI or ARB | Experimental | 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) Receives: Drug: Hold ACEI or ARB |
| Continue ACE1 or ARB | Other | Randomized to continue on prescribed ACE1 or ARB Receives: Drug: Hold ACEI or ARB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast induced nephropathy (creatinine rise of 44umol/L or 25% compared to the pre-randomization creatinine level) at 48-96hrs
Measured: 48 - 96 hours post-cardiac catheterization
Secondary outcomes (3)
Change in serum creatinine at 48-96hrs
Measured: 48 - 96 hours post-cardiac catheterization
Change in creatinine clearance at 48-96hrs
Measured: 48 - 96 hours post-cardiac catheterization
Death, Myocardial Infarction, Stroke, Congestive Heart Failure, dialysis, major bleeding, minor bleeding, hypertension, re-hospitalization at 48-96hrs.
Measured: 48 - 96 hours post-cardiac catheterization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2006 (estimated)
- Study startJul 2006
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Shamir Mehta, McMaster University
- Investigators
- Shamir R Mehta, MD MSc, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00317252
- Sponsor's protocol ID
- 06-005
- Status last verified
- Oct 2012
- First submitted
- 20 Apr 2006
- Last updated
- 22 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Bainey KR, Rahim S, Etherington K, Rokoss ML, Natarajan MK, Velianou JL, Brons S, Mehta SR; CAPTAIN Investigators. Effects of withdrawing vs continuing renin-angiotensin blockers on incidence of acute kidney injury in patients with renal insufficiency undergoing cardiac catheterization: Results from the Angiotensin Converting Enzyme Inhibitor/Angiotensin Receptor Blocker and Contrast Induced Nephropathy in Patients Receiving Cardiac Catheterization (CAPTAIN) trial. Am Heart J. 2015 Jul;170(1):110-6. doi: 10.1016/j.ahj.2015.04.019. Epub 2015 Apr 18.
PubMed 26093871
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Angiotensin Converting Enzyme Inhibitors and Contrast Induced Nephropathy in Patients Receiving a Cardiac Catheterization "The CAPTAIN Trial"
- ClinicalTrials.gov ID
- NCT00317252
- Acronym / sponsor ID
- 06-005
- Conditions
- Kidney Failure
- Keywords
- contrast induced nephropathy, contrast nephropathy, contrast media, kidney diseases, angiotensin converting enzyme inhibitors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 24 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hold ACEI or ARB | Experimental | Drug: Hold ACEI or ARBAngiotensin converting enzyme inhibitor or angiotensin receptor blocker held >= 24 hours pre-cardiac catheterization and restarted post-catheterization after creatinine measurement (48-96 hours post) |
| Continue ACE1 or ARB | Other | Drug: Hold ACEI or ARBRandomized to continue on prescribed ACE1 or ARB |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Patients with end stage renal disease (for example, patient on dialysis)
- Emergency Cardiac Catheterization with insufficient time to hold the ACEI
- Acute Pulmonary Edema
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hold ACEI or ARBAlso: Includes all ACE inhibitors or ARBsAngiotensin 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) | Drug | Continue ACE1 or ARB, Hold ACEI or ARB |
Primary outcome
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
3 secondary outcomes
Change in serum creatinine at 48-96hrs
Time frame: 48 - 96 hours post-cardiac catheterization
Change in creatinine clearance at 48-96hrs
Time frame: 48 - 96 hours post-cardiac catheterization
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2012.
- Derived from this study: PubMed 26093871Bainey KR, Rahim S, Etherington K, Rokoss ML, Natarajan MK, Velianou JL, Brons S, Mehta SR; CAPTAIN Investigators. Effects of withdrawing vs continuing renin-angiotensin blockers on incidence of acute kidney injury in patients with renal insufficiency undergoing cardiac catheterization: Results from the Angiotensin Converting Enzyme Inhibitor/Angiotensin Receptor Blocker and Contrast Induced Nephropathy in Patients Receiving Cardiac Catheterization (CAPTAIN) trial. Am Heart J. 2015 Jul;170(1):110-6. doi: 10.1016/j.ahj.2015.04.019. Epub 2015 Apr 18.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shamir R Mehta, MD MSc principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hold ACEI or ARB in people with Kidney Failure, run by Hamilton Health Sciences Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00317252, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2012.