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The Link Between BRCA Mutation and Endothelial Function

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ClinicalTrials.gov Identifier: NCT02474264
Recruitment Status : Unknown
Verified October 2016 by Rabin Medical Center.
Recruitment status was:  Recruiting
First Posted : June 17, 2015
Last Update Posted : July 18, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
BRCA1 Gene Mutation BRCA2 Gene Mutation Other: Endothelial function assessment Other: Cardiovascular biomarkers Other: Endothelial cells Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 82 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: The Link Between BRCA Mutation and Endothelial Function - A Pilot Study
Study Start Date : February 2015
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : November 2018

Arm Intervention/treatment
male BRCA mutations carriers
Endothelial function assessment and Cardiovascular biomarkers
Other: Endothelial function assessment
reactive hyperemia index

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)

Other: Endothelial cells
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
Other: Endothelial function assessment
reactive hyperemia index

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)

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




Primary Outcome Measures :
  1. reactive hyperemia index will be assessed using the Endo-PAT2000 [ Time Frame: at baseline ]
    will be assessed using the Endo-PAT2000


Secondary Outcome Measures :
  1. The level of high sensitivity troponin (hsTn) - a cardiovascular risk biomarker will be measured [ Time Frame: at baseline ]
    high sensitivity troponin (hsTn)

  2. The level of C-reactive protein - a cardiovascular risk biomarker will be measured [ Time Frame: at baseline ]
    C-reactive protein

  3. The level of D-dimer - a cardiovascular risk biomarker will be measured [ Time Frame: at baseline ]
    D-dimer

  4. The level of N-terminal pro-brain natriuretic peptide (NT-proBNP) - a cardiovascular risk biomarker will be measured [ Time Frame: at baseline ]
    N-terminal pro-brain natriuretic peptide (NT-proBNP)

  5. Endothelial Progenitor Cells profile (EPC) - will be characterized to evaluate endothelial injury. [ Time Frame: at baseline ]
    Endothelial Progenitor Cells (EPC)

  6. Circulating Endothelial Cells profile (CEC) - will be characterized to evaluate endothelial injury. [ Time Frame: at baseline ]
    Circulating Endothelial Cells (CEC)



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02474264


Contacts
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Contact: David Margel, MD, PhD +972(0)39376553 sdmargel@gmail.com

Locations
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Israel
Rabin Medical Center, Beilinson Hospital Recruiting
Petah Tikva, Israel
Contact: David Margel, MD PhD    +972(0)39376553      
Principal Investigator: David Margel, MD Phd         
Sponsors and Collaborators
Rabin Medical Center
Investigators
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Principal Investigator: David Margel, MD, PhD Rabn Medical Center, Beilinson Campus
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Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT02474264    
Other Study ID Numbers: 0594-14-RMC
First Posted: June 17, 2015    Key Record Dates
Last Update Posted: July 18, 2017
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided