The Link Between BRCA Mutation and Endothelial Function

Not Applicable

• Conditions: BRCA1 Gene Mutation; BRCA2 Gene Mutation
• Interventions: Other: Endothelial function assessment; Other: Cardiovascular biomarkers; Other: Endothelial cells

• Registration Number: NCT02474264
• Lead Sponsor: Rabin Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-23
• Study First Submitted QC: 2015-06-12
• Study First Posted: 2015-06-17
• Status Verified: 2016-10
• Last Update Submitted: 2017-07-13
• Last Update Posted: 2017-07-18
• Primary Completion: 2018-07
• Study Completion: 2018-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 82

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
male BRCA mutations carriers	Endothelial function assessment	Endothelial function assessment and Cardiovascular biomarkers
healthy males - control group	Endothelial function assessment	Endothelial function assessment and Cardiovascular biomarkers
male BRCA mutations carriers	Cardiovascular biomarkers	Endothelial function assessment and Cardiovascular biomarkers
healthy males - control group	Endothelial cells	Endothelial function assessment and Cardiovascular biomarkers
male BRCA mutations carriers	Endothelial cells	Endothelial function assessment and Cardiovascular biomarkers
healthy males - control group	Cardiovascular biomarkers	Endothelial function assessment and Cardiovascular biomarkers

Primary Outcome Measures

Name	Time	Method
reactive hyperemia index will be assessed using the Endo-PAT2000	at baseline	will be assessed using the Endo-PAT2000

Secondary Outcome Measures

Name	Time	Method
The level of N-terminal pro-brain natriuretic peptide (NT-proBNP) - a cardiovascular risk biomarker will be measured	at baseline	N-terminal pro-brain natriuretic peptide (NT-proBNP)
Endothelial Progenitor Cells profile (EPC) - will be characterized to evaluate endothelial injury.	at baseline	Endothelial Progenitor Cells (EPC)
The level of high sensitivity troponin (hsTn) - a cardiovascular risk biomarker will be measured	at baseline	high sensitivity troponin (hsTn)
The level of D-dimer - a cardiovascular risk biomarker will be measured	at baseline	D-dimer
Circulating Endothelial Cells profile (CEC) - will be characterized to evaluate endothelial injury.	at baseline	Circulating Endothelial Cells (CEC)
The level of C-reactive protein - a cardiovascular risk biomarker will be measured	at baseline	C-reactive protein

Trial Locations

Locations (1)

Rabin Medical Center, Beilinson Hospital; 🇮🇱 Petah Tikva, Israel