The Link Between BRCA Mutation and Endothelial Function

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2018-11-30

Brief Summary

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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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Detailed Description

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Conditions

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BRCA1 Gene Mutation BRCA2 Gene Mutation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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male BRCA mutations carriers

Endothelial function assessment and Cardiovascular biomarkers

Group Type OTHER

Endothelial function assessment

Intervention Type OTHER

reactive hyperemia index

Cardiovascular biomarkers

Intervention Type 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

Intervention Type OTHER

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

healthy males - control group

Endothelial function assessment and Cardiovascular biomarkers

Group Type OTHER

Endothelial function assessment

Intervention Type OTHER

reactive hyperemia index

Cardiovascular biomarkers

Intervention Type 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

Intervention Type OTHER

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

Interventions

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Endothelial function assessment

reactive hyperemia index

Intervention Type OTHER

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)

Intervention Type OTHER

Endothelial cells

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

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes