The HEART BREAK Study

Coronary Artery Disease Clinical Trial

Official title:

Effects of Heart Imaging Radiation on DNA Double-Stranded Breaks in Blood Lymphocytes and Hair Follicle Cells

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02617888
• Other study ID #: 362425
• Status: Completed
• Phase: N/A
• First received: November 19, 2015
• Last updated: November 30, 2015
• Start date: March 2011

Study information

• Verified date: November 2015
• Source: Walter Reed National Military Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial Summary

Purpose

1. To investigate the effects of cardiac imaging radiation on the induction of DNA double-strand breaks by enumerating gamma-H2AX foci in blood lymphocytes and plucked hair follicle cells.

2. To estimate whether the use of breast shields in cardiac computed tomographic angiography (CCTA) limits the effective radiation exposure of breast tissue.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 228
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult male and female adult subjects (age greater than 18 years)

• Referred for cardiac computed tomography angiography (CCTA), myocardial perfusion scintigraphy (MPS), or diagnostic invasive coronary angiography (ICA).

Exclusion Criteria:

• Female patients that identify themselves as pregnant or have a positive pregnancy test prior to cardiac imaging.

• History (present or past) of leukemia or lymphoma.

• History of radiation therapy

• X-ray examination or scintigraphy within the last 72 hours.

• History of coronary revascularization (coronary artery bypass grafting or percutaneous coronary intervention)

• Patients undergoing percutaneous coronary intervention at completion of diagnostic left heart catheterization

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Chest Pain
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Radiation:
• CCTA
Breast shield placement (randomized) among women.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Walter Reed National Military Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of double-strand DNA break foci per cell in peripheral blood samples	Number of excess foci/cell defined as post imaging minus baseline value (at 30 minutes)	Change from baseline double strand DNA breaks at 30 minutes post-imaging	No