The Link Between BRCA Mutation and Endothelial Function

Clalit Health Services

Status: Unknown

Conditions: BRCA2 Gene Mutation; BRCA1 Gene Mutation

Treatments: Other: Endothelial cells; Other: Endothelial function assessment; Other: Cardiovascular biomarkers

Study type: Interventional

Funder types: Other

Identifiers

NCT02474264

0594-14-RMC

Details and patient eligibility

About

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.

Enrollment: 82 estimated patients

Sex: Male

Ages: 18 to 70 years old

Volunteers: 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)

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

82 participants in 2 patient groups

male BRCA mutations carriers

Other group

Description:

Endothelial function assessment and Cardiovascular biomarkers

Treatment:

Other: Cardiovascular biomarkers

Other: Endothelial function assessment

Other: Endothelial cells

healthy males - control group

Other group

Description:

Endothelial function assessment and Cardiovascular biomarkers

Treatment:

Other: Cardiovascular biomarkers

Other: Endothelial function assessment

Other: Endothelial cells