Effect of BNP (Brain Natriuretic Peptides) on Endothelial... | NCT00262574

Studies
Effect of BNP (Brain Natriuretic Peptides) on Endothelial Dysfunction Induced by Coronary Angioplasty

NCT00262574

Sponsor

The Baruch Padeh Medical Center, Poriya

Status

Unknown status

Last Update Posted

Aug 9, 2011Estimated

Enrollment

500Estimated

Phase

Phase 4

Conditions

Coronary Artery Disease

Interventions

Nesiritide,

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2005

Primary Completion Date

Apr 2012Estimated

Completion Date

Jun 2013Estimated

First Submitted Date

Dec 6, 2005

First Submission Date that Met QC Criteria

Dec 6, 2005

First Posted Date

Dec 7, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 8, 2011

Last Update Posted Date

Aug 9, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Name	Type	Description	Arm Group Labels	Other Names
Nesiritide,	Drug	PCI

Measure	Description	Time Frame
FMD		3 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:coronary artery disease -

Exclusion Criteria:CHF and/or reduced LV function, or renal failure with Creatinine >2mg%

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yonathan Hasin, prof.	Contact	97246652649		yhasin@poria.health.gov.il
Diab gahnim, Dr	Contact

Overall Officials

Name	Affiliation	Role
Mina Arinos	Ministry of Health, Israel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Baruch Pade medical center, Poriya	Recruiting	Tiberias		15208	Israel

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020097	Natriuretic Peptide, Brain

Ancestor Terms

ID	Term
D045265	Natriuretic Peptides
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists

Browse Leaves

Not provided

Browse Branches

Not provided