NCT02474264

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

February 23, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 17, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

July 18, 2017

Status Verified

October 1, 2016

Enrollment Period

3.4 years

First QC Date

February 23, 2015

Last Update Submit

July 13, 2017

Conditions

BRCA1 Gene MutationBRCA2 Gene Mutation

Outcome Measures

Primary Outcomes (1)

  • reactive hyperemia index will be assessed using the Endo-PAT2000

    will be assessed using the Endo-PAT2000

    at baseline

Secondary Outcomes (6)

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

    at baseline

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

    at baseline

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

    at baseline

  • The level of N-terminal pro-brain natriuretic peptide (NT-proBNP) - a cardiovascular risk biomarker will be measured

    at baseline

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

    at baseline

  • +1 more secondary outcomes

Study Arms (2)

male BRCA mutations carriers

OTHER

Endothelial function assessment and Cardiovascular biomarkers

Other: Endothelial function assessmentOther: Cardiovascular biomarkersOther: Endothelial cells

healthy males - control group

OTHER

Endothelial function assessment and Cardiovascular biomarkers

Other: Endothelial function assessmentOther: Cardiovascular biomarkersOther: Endothelial cells

Interventions

Endothelial function assessmentOTHER

reactive hyperemia index

healthy males - control groupmale BRCA mutations carriers
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)

healthy males - control groupmale BRCA mutations carriers
Endothelial cellsOTHER

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

healthy males - control groupmale BRCA mutations carriers

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Known carrier or non-carrier, confirmed by genetic testing of BRCA 1/2 mutation
  • Able and willing to sign an informed consent

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rabin Medical Center, Beilinson Hospital

Petah Tikva, Israel

RECRUITING

Study Officials

  • David Margel, MD, PhD

    Rabn Medical Center, Beilinson Campus

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David Margel, MD, PhD

CONTACT

+972(0)39376553sdmargel@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2015

First Posted

June 17, 2015

Study Start

February 1, 2015

Primary Completion

July 1, 2018

Study Completion

November 1, 2018

Last Updated

July 18, 2017

Record last verified: 2016-10

Locations

IL(1)