N/A N=228 Randomized Diagnostic

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

Coronary Artery Disease · Chest Pain

Bottom Line

View on ClinicalTrials.gov: NCT02617888 ↗

Enrolled (actual)

228

Serious AEs

0.0%

Results posted

Jan 2017

Primary outcome: Primary: Number of Excess Double-strand DNA Break Foci Per Cell in Peripheral Blood Samples Post-imaging — 0.183; 0.159 gamma-H2AX foci in blood lymphocytes — p=<0.05

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: CCTA ~ BREAST SHIELDS (Radiation)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Walter Reed National Military Medical Center
Primary completion: Sep 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Excess Double-strand DNA Break Foci Per Cell in Peripheral Blood Samples Post-imaging	0.183; 0.159	<0.05 sig

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.

Eligibility Criteria

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

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Data sourced from ClinicalTrials.gov (NCT02617888). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.