Coronary Artery DiseasePhase 4NCT00262574
Effect of BNP (Brain Natriuretic Peptides) on Endothelial Dysfunction Induced by Coronary Angioplasty
A Phase 4 study testing Nesiritide, in people with Coronary Artery Disease, run by The Baruch Padeh Medical Center, Poriya at 1 site in Israel.
Trial summary
Patients receiving BNP or nitroglycerin (IV) during the angioplasty procedure. 24 h after the procedure, vascular reactivity will be re-examined using the brachial artery flow-mediated dilatation study. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Nesiritide,
- How many people
- 500 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2005to Jun 2013
- Phase
- Phase 4
- 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
- Exclusion Criteria:CHF and/or reduced LV function, or renal failure with Creatinine >2mg%
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Diab gahnim, Dr contact
Israel1 site, 1 recruiting
- Recruiting
The Baruch Pade medical center, Poriya
Tiberias, 15208
Yonathan Hasin, Profesor
About this study
Official title: Phase 4 Study of Patients Receiving BNP or NTG (IV) During Angioplasty, Re-examined 24 Hours Later Using the Flow-mediated Brachial Artery Dilation Study, and Blood Assays for Pro BNP and ET1
Patients receiving BNP or nitroglycerin (IV) during the angioplasty procedure. 24 h after the procedure, vascular reactivity will be re-examined using the brachial artery flow-mediated dilatation study. Blood assays for ET-1, pro-BNP, and various inflammatory markers will be checked before and 24 h after the procedure. It is our hypothesis that endothelial function will be better in the BNP treated patients compared to the NTG treated patients
- Conditions
- Coronary Artery Disease
- Being tested
- Nesiritide,
- Keywords
- endothelial disfunction, BNP, PCI, coronary artery disease
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nesiritide,Drug
PCI
What is being measured
The primary outcome is the main question the study is designed to answer.
FMD
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2005 (estimated)
- Study startJul 2005
- Primary completionApr 2012 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Baruch Padeh Medical Center, Poriya
- Sponsor type
- Other government
- Investigators
- Mina Arinos, Principal investigator, Ministry of Health, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00262574
- Sponsor's protocol ID
- 20020474-Hasin-BNP.CTIL
- Status last verified
- Dec 2010
- First submitted
- 6 Dec 2005
- Last updated
- 9 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of Patients Receiving BNP or NTG (IV) During Angioplasty, Re-examined 24 Hours Later Using the Flow-mediated Brachial Artery Dilation Study, and Blood Assays for Pro BNP and ET1
- ClinicalTrials.gov ID
- NCT00262574
- Acronym / sponsor ID
- 20020474-Hasin-BNP.CTIL
- Conditions
- Coronary Artery Disease
- Keywords
- endothelial disfunction, BNP, PCI, coronary artery disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- The Baruch Padeh Medical Center, PoriyaOther government
- Study start
- Jul 2005
- Primary completion
- Apr 2012 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 7 Dec 2005 (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.
Patients receiving BNP or nitroglycerin (IV) during the angioplasty procedure. 24 h after the procedure, vascular reactivity will be re-examined using the brachial artery flow-mediated dilatation study. Blood assays for ET-1, pro-BNP, and various inflammatory markers will be checked before and 24 h after the procedure. It is our hypothesis that endothelial function will be better in the BNP treated patients compared to the NTG treated patients
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Exclusion Criteria:CHF and/or reduced LV function, or renal failure with Creatinine >2mg%
- -
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Nesiritide,PCI | Drug | – |
Primary outcome
FMD
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2011.
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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.
Diab gahnim, Dr contact
Mina Arinos principal investigator
Ministry of Health, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nesiritide, in people with Coronary Artery Disease, run by The Baruch Padeh Medical Center, Poriya 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 2 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 9 Aug 2011. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yonathan Hasin, prof. (97246652649, yhasin@poria.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FMD (time frame: 3 years). 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 9 Aug 2011.