The Link Between BRCA Mutation and Endothelial Function

BRCA1 Gene Mutation Clinical Trial

Official title:

The Link Between BRCA Mutation and Endothelial Function - A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02474264
• Other study ID #: 0594-14-RMC
• Status: Recruiting
• Phase: N/A
• First received: February 23, 2015
• Last updated: July 13, 2017
• Start date: February 2015
• Est. completion date: November 2018

Study information

• Verified date: October 2016
• Source: Rabin Medical Center
• Contact: David Margel, MD, PhD
• Phone: +972(0)39376553
• Email: sdmargel[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the effect of BRCA1&2 mutations on cardiovascular diseases by to comparing the endothelial function of male BRCA mutation carriers with that of age matched non-BRCA mutation carriers.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: November 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Known carrier or non-carrier, confirmed by genetic testing of BRCA 1/2 mutation

• Able and willing to sign an informed consent

Exclusion Criteria:

• History of, or current, malignancy

• History of:

• Myocardial infarction

• Ischemic or Hemorrhagic cerebrovascular conditions

• Arterial embolic and thrombotic events

• Ischemic heart disease

• Prior coronary artery or ilio-femoral artery revascularization (percutaneous or surgical procedures)

• Peripheral vascular disease (e.g. claudication, prior vascular surgery/intervention)

Related Conditions & MeSH terms

• BRCA1 Gene Mutation
• BRCA2 Gene Mutation

Intervention

Other:
• Endothelial function assessment
reactive hyperemia index
• Cardiovascular biomarkers
Cardiovascular biomarkers will be measure to test other aspects of endothelial and cardiac function: high-sensitivity troponin (hsTn) , C-reactive protein , D-dimer, N-terminal pro-brain natriuretic peptide (NT-proBNP)
• Endothelial cells
Endothelial Progenitor Cells and Circulating Endothelial Cells profiles- will be characterized to evaluate endothelial injury.

Locations

Country	Name	City	State
Israel	Rabin Medical Center, Beilinson Hospital	Petah Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reactive hyperemia index will be assessed using the Endo-PAT2000	will be assessed using the Endo-PAT2000	at baseline
Secondary	The level of high sensitivity troponin (hsTn) - a cardiovascular risk biomarker will be measured	high sensitivity troponin (hsTn)	at baseline
Secondary	The level of C-reactive protein - a cardiovascular risk biomarker will be measured	C-reactive protein	at baseline
Secondary	The level of D-dimer - a cardiovascular risk biomarker will be measured	D-dimer	at baseline
Secondary	The level of N-terminal pro-brain natriuretic peptide (NT-proBNP) - a cardiovascular risk biomarker will be measured	N-terminal pro-brain natriuretic peptide (NT-proBNP)	at baseline
Secondary	Endothelial Progenitor Cells profile (EPC) - will be characterized to evaluate endothelial injury.	Endothelial Progenitor Cells (EPC)	at baseline
Secondary	Circulating Endothelial Cells profile (CEC) - will be characterized to evaluate endothelial injury.	Circulating Endothelial Cells (CEC)	at baseline