Blood PressureNCT01071642
The Influence of Angiotensin Converting Enzyme Inhibitors and Angiotensin Receptor Blockers on Renal Function in Patients Undergoing Non-emergent Coronary Angiography
A study testing stop ace-i/arb 24 h before procedure and restarted 24 hours after the procedure and ACE/ARB stopped 24 hours before procedure and start immediately after in people with Blood Pressure, run by Soroka University Medical Center at 1 site in Israel.
Trial summary
The aim of the current study is to evaluate prospectively whether concomitant administration of RAAS blockers (namely ACE-I and ARBs') influence the change in estimated GFR (eGFR) after administration of contrast media in patients undergoing non-emergent coronary angiography. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Blood Pressure
- What is being tested?
- stop ace-i/arb 24 h before procedure and restarted 24 hours after the procedure and ACE/ARB stopped 24 hours before procedure and start immediately after
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2010to Nov 2010
- Phase
- Interventional
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Age>18 years
- 2. Subjects on chronic therapy with ACE-I and/or ARBs' (confirmed by electronic records in their medical file)
- 3. Subjects planned to undergo non-emergent coronary angiography.
- 4. Signed informed consent
Who cannot join
- 1. eGFR<30 ml/min at baseline
- 2. Chronic utilization of NSAIDS and Cox-2 selective inhibitors
- 3. Chronic treatment with mineralocorticosteroid receptor blocker
- 4. Systolic blood pressure<90 mmHg
- 5. Planned staged (repeated) procedure within 48 hours
- 6. Administration of contrast within 14 days prior to the enrollment
- 7. contraindication to stop ACE-I or ARB'S
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the current study is to evaluate prospectively whether concomitant administration of RAAS blockers (namely ACE-I and ARBs') influence the change in estimated GFR (eGFR) after administration of contrast media in patients undergoing non-emergent coronary angiography.
- Conditions
- Blood Pressure
- Being tested
- stop ace-i/arb 24 h before procedure and restarted 24 hours after the procedure, ACE/ARB stopped 24 hours before procedure and start immediately after
- Keywords
- Change in eGFR from baseline to 72 hours following the exposure to the contrast., Rate of eGFR decrease>25% from the baseline, Length of hospitalization., Requirement of unplanned therapy for elevated blood pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stop ace-i/arb 24 h before procedure and restarted 24 hours after the procedureDrug
ACE/ARB stopped 24 hours prior to the procedure and restarted 24 hours after the procedure
ACE/ARB stopped 24 hours before procedure and start immediately afterDrug
ACE/ARB stopped 24 hours prior to the procedure and restarted immediately after the procedure
| Study group | Role | What they receive |
|---|---|---|
| continue ace-i and arb's versus dicontinue | No intervention | Not described |
| group b | Active comparator | Not described Receives: Drug: stop ace-i/arb 24 h before procedure and restarted 24 hours after the procedure |
| group c | Active comparator | Not described Receives: Drug: ACE/ARB stopped 24 hours before procedure and start immediately after |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in eGFR from baseline to 48 hours following the exposure to the contrast.
Measured: 48 hours after exposure to the contrast
Secondary outcomes (1)
1. Rate of eGFR decrease>25% from the baseline, 2. Length of hospitalization,
Measured: 48-72 hours after exposure to contrast
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2010 (estimated)
- Study startMar 2010
- Primary completionSep 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Talya Wolak, Soroka University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01071642
- Sponsor's protocol ID
- sor495209ctil
- Status last verified
- Jun 2017
- First submitted
- 18 Feb 2010
- Last updated
- 21 Jun 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Angiotensin Converting Enzyme Inhibitors and Angiotensin Receptor Blockers on Renal Function in Patients Undergoing Non-emergent Coronary Angiography
- ClinicalTrials.gov ID
- NCT01071642
- Acronym / sponsor ID
- sor495209ctil
- Conditions
- Blood Pressure
- Keywords
- Change in eGFR from baseline to 72 hours following the exposure to the contrast., Rate of eGFR decrease>25% from the baseline, Length of hospitalization., Requirement of unplanned therapy for elevated blood pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 19 Feb 2010 (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 aim of the current study is to evaluate prospectively whether concomitant administration of RAAS blockers (namely ACE-I and ARBs') influence the change in estimated GFR (eGFR) after administration of contrast media in patients undergoing non-emergent coronary angiography.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| continue ace-i and arb's versus dicontinue | No intervention | – |
| group b | Active comparator | Drug: stop ace-i/arb 24 h before procedure and restarted 24 hours after the procedure |
| group c | Active comparator | Drug: ACE/ARB stopped 24 hours before procedure and start immediately after |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1. Age>18 years
- 2. Subjects on chronic therapy with ACE-I and/or ARBs' (confirmed by electronic records in their medical file)
- 3. Subjects planned to undergo non-emergent coronary angiography.
- 4. Signed informed consent
Key exclusion criteria (7 listed)
- 1. eGFR<30 ml/min at baseline
- 2. Chronic utilization of NSAIDS and Cox-2 selective inhibitors
- 3. Chronic treatment with mineralocorticosteroid receptor blocker
- 4. Systolic blood pressure<90 mmHg
- 5. Planned staged (repeated) procedure within 48 hours
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 |
|---|---|---|
| stop ace-i/arb 24 h before procedure and restarted 24 hours after the procedureACE/ARB stopped 24 hours prior to the procedure and restarted 24 hours after the procedure | Drug | group b |
| ACE/ARB stopped 24 hours before procedure and start immediately afterACE/ARB stopped 24 hours prior to the procedure and restarted immediately after the procedure | Drug | group c |
Primary outcome
Change in eGFR from baseline to 48 hours following the exposure to the contrast.
Time frame: 48 hours after exposure to the contrast
1 secondary outcome
1. Rate of eGFR decrease>25% from the baseline, 2. Length of hospitalization,
Time frame: 48-72 hours after exposure to contrast
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 21 Jun 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stop ace-i/arb 24 h before procedure and restarted 24 hours after the procedure and ACE/ARB stopped 24 hours before procedure and start immediately after in people with Blood Pressure, run by Soroka University Medical Center at 1 site in Israel.
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 4 inclusion and 7 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 21 Jun 2017. 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 Israel. 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.
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?
Change in eGFR from baseline to 48 hours following the exposure to the contrast. (time frame: 48 hours after exposure to the contrast). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jun 2017.