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

Primary Purpose

Coronary Artery Disease

Status

Unknown status

Phase

Phase 4

Locations

Israel

Study Type

Interventional

Intervention

Nesiritide,

About this trial

This is an interventional supportive care trial for Coronary Artery Disease focused on measuring endothelial disfunction, BNP, PCI, coronary artery disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:coronary artery disease - Exclusion Criteria:CHF and/or reduced LV function, or renal failure with Creatinine >2mg% -

Sites / Locations

The Baruch Pade medical center, PoriyaRecruiting

Outcomes

Primary Outcome Measures

FMD

Secondary Outcome Measures

Full Information

NCT ID

NCT00262574

First Posted

December 6, 2005

Last Updated

August 8, 2011

Sponsor

The Baruch Padeh Medical Center, Poriya

1. Study Identification

Unique Protocol Identification Number

NCT00262574

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2010

Overall Recruitment Status

Unknown status

Study Start Date

July 2005 (undefined)

Primary Completion Date

April 2012 (Anticipated)

Study Completion Date

June 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

The Baruch Padeh Medical Center, Poriya

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

Keywords

endothelial disfunction, BNP, PCI, coronary artery disease

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

500 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Nesiritide,

Intervention Description

PCI

Primary Outcome Measure Information:

Title

FMD

Time Frame

3 years

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria:coronary artery disease - Exclusion Criteria:CHF and/or reduced LV function, or renal failure with Creatinine >2mg% -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yonathan Hasin, prof.

Phone

97246652649

yhasin@poria.health.gov.il

First Name & Middle Initial & Last Name or Official Title & Degree

Diab gahnim, Dr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mina Arinos

Organizational Affiliation

Ministry of Health, Israel

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Baruch Pade medical center, Poriya

City

Tiberias

ZIP/Postal Code

15208

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yonathan Hasin, Profesor

12. IPD Sharing Statement

Learn more about this trial

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

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