The Link Between BRCA Mutation and Endothelial Function

Rabin Medical Center82 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

Conditions

BRCA1 Gene Mutation BRCA2 Gene Mutation

Interventions

Endothelial function assessmentOTHER

reactive hyperemia index

Cardiovascular biomarkersOTHER

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 cellsOTHER

Endothelial Progenitor Cells and Circulating Endothelial Cells profiles- will be characterized to evaluate endothelial injury.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Rabin Medical Center, Beilinson Hospital

Petah Tikva, Israel

RECRUITING

Outcomes

Primary Outcomes

reactive hyperemia index will be assessed using the Endo-PAT2000

will be assessed using the Endo-PAT2000

Time frame: at baseline

Secondary Outcomes

The level of high sensitivity troponin (hsTn) - a cardiovascular risk biomarker will be measured

high sensitivity troponin (hsTn)

Time frame: at baseline

The level of C-reactive protein - a cardiovascular risk biomarker will be measured

C-reactive protein

Time frame: at baseline

The level of D-dimer - a cardiovascular risk biomarker will be measured

D-dimer

Time frame: at baseline

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)

Time frame: at baseline

Endothelial Progenitor Cells profile (EPC) - will be characterized to evaluate endothelial injury.

Endothelial Progenitor Cells (EPC)

Time frame: at baseline

Circulating Endothelial Cells profile (CEC) - will be characterized to evaluate endothelial injury.

Circulating Endothelial Cells (CEC)

Time frame: at baseline

Central Contacts

David Margel, MD, PhD

CONTACT

+972(0)39376553 sdmargel@gmail.com

Data from ClinicalTrials.gov

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