The Link Between BRCA Mutation and Endothelial Function

NCT02474264 — Not applicable, Unknown, 82 participants, Rabin Medical Center

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

Registry	NCT02474264
Status	Unknown
Phase	Not applicable
Study type	Interventional; non randomized, crossover, masking: none, screening
Enrollment	82 (Estimated)
Sponsor	Rabin Medical Center (Other)
Conditions	BRCA1 Gene Mutation, BRCA2 Gene Mutation
Interventions	Endothelial function assessment, Cardiovascular biomarkers, Endothelial cells (Other)
Dates	start 2015-02-01, primary completion 2018-07-01 (estimated), completion 2018-11-01 (estimated), first posted 2015-06-17, last updated 2017-07-18
Locations	1 site in Israel

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
male BRCA mutations carriers	Other	Other: Endothelial function assessment; Other: Cardiovascular biomarkers; Other: Endothelial cells	Endothelial function assessment and Cardiovascular biomarkers
healthy males - control group	Other	Other: Endothelial function assessment; Other: Cardiovascular biomarkers; Other: Endothelial cells	Endothelial function assessment and Cardiovascular biomarkers

Endothelial function assessment (Other): reactive hyperemia index
Cardiovascular biomarkers (Other): 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 (Other): Endothelial Progenitor Cells and Circulating Endothelial Cells profiles- will be characterized to evaluate endothelial injury.

+Outcome measures

Primary outcomes

reactive hyperemia index will be assessed using the Endo-PAT2000 [at baseline]: will be assessed using the Endo-PAT2000

Secondary outcomes

The level of high sensitivity troponin (hsTn) - a cardiovascular risk biomarker will be measured [at baseline]: high sensitivity troponin (hsTn)
The level of C-reactive protein - a cardiovascular risk biomarker will be measured [at baseline]: C-reactive protein
The level of D-dimer - a cardiovascular risk biomarker will be measured [at baseline]: D-dimer
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)
Circulating Endothelial Cells profile (CEC) - will be characterized to evaluate endothelial injury. [at baseline]: Circulating Endothelial Cells (CEC)

+Eligibility

Sex: Male, ages: 18 Years to 70 Years, accepts healthy volunteers

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)

Facility	City	Country	Status
Rabin Medical Center, Beilinson Hospital	Petah Tikva	Israel	Recruiting

+Investigators

David Margel, MD, PhD, Principal investigator, Rabn Medical Center, Beilinson Campus

My Notes

Public

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