NCT00262574

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for phase_4 coronary-artery-disease

Timeline
Completed

Started Jul 2005

Longer than P75 for phase_4 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 7, 2005

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

August 9, 2011

Status Verified

December 1, 2010

Enrollment Period

6.8 years

First QC Date

December 6, 2005

Last Update Submit

August 8, 2011

Conditions

Keywords

endothelial disfunctionBNPPCIcoronary artery disease

Outcome Measures

Primary Outcomes (1)

  • FMD

    3 years

Interventions

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Baruch Pade medical center, Poriya

Tiberias, 15208, Israel

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Natriuretic Peptide, Brain

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Natriuretic PeptidesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

Study Officials

  • Mina Arinos

    Ministry of Health, Israel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yonathan Hasin, prof.

CONTACT

Diab gahnim, Dr

CONTACT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

December 6, 2005

First Posted

December 7, 2005

Study Start

July 1, 2005

Primary Completion

April 1, 2012

Study Completion

June 1, 2013

Last Updated

August 9, 2011

Record last verified: 2010-12

Locations