Effect of BNP (Brain Natriuretic Peptides) on Endothelial Dysfunction Induced by Coronary Angioplasty
This study is currently recruiting participants.
Verified December 2010 by The Baruch Padeh Medical Center, Poriya
Sponsor:
The Baruch Padeh Medical Center, Poriya
Information provided by:
The Baruch Padeh Medical Center, Poriya
ClinicalTrials.gov Identifier:
NCT00262574
First received: December 6, 2005
Last updated: August 8, 2011
Last verified: December 2010
| Tracking Information | |||||||||
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| First Received Date ICMJE | December 6, 2005 | ||||||||
| Last Updated Date | August 8, 2011 | ||||||||
| Start Date ICMJE | July 2005 | ||||||||
| Estimated Primary Completion Date | April 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
FMD [ Time Frame: 3 years ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE |
FMD-flow mediated dilatation | ||||||||
| Change History | Complete list of historical versions of study NCT00262574 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Effect of BNP (Brain Natriuretic Peptides) on Endothelial Dysfunction Induced by Coronary Angioplasty | ||||||||
| Official Title ICMJE | 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 | ||||||||
| Brief 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. 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 |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 4 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Supportive Care |
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| Condition ICMJE | Coronary Artery Disease | ||||||||
| Intervention ICMJE | Drug: Nesiritide,
PCI |
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| Study Arm (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 500 | ||||||||
| Estimated Completion Date | June 2013 | ||||||||
| Estimated Primary Completion Date | April 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:coronary artery disease - Exclusion Criteria:CHF and/or reduced LV function, or renal failure with Creatinine >2mg% - |
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| Gender | Both | ||||||||
| Ages | Not Provided | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Israel | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00262574 | ||||||||
| Other Study ID Numbers ICMJE | 20020474-Hasin-BNP.CTIL | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | prof yonathan hasin, Israell health ministry | ||||||||
| Study Sponsor ICMJE | The Baruch Padeh Medical Center, Poriya | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | The Baruch Padeh Medical Center, Poriya | ||||||||
| Verification Date | December 2010 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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