Trial Outcomes & Findings for Effects of Heart Imaging Radiation on DNA Double-Stranded Breaks in Blood Lymphocytes and Hair Follicle Cells (NCT NCT02617888)

Last Updated: 2017-07-11

Results Overview

The amount of excess DNA double-strand break foci per cell after cardiac computed tomographic angiography (CCTA) in female patients with and without breast shields, minus the amount of foci prior to CCTA. In addition, changes in DNA double-strand breaks from baseline following cardiac testing in the observational arm is being assessed in an observational manner.

Recruitment status

COMPLETED

Study phase

Target enrollment

228 participants

Primary outcome timeframe

Change from baseline double strand DNA breaks at 30 minutes post-imaging

Results posted on

2017-07-11

Participant Flow

101 patients enrolled in intervention arms (breast shields). Other patients in observational arm (not completed analysis).

Participant milestones

Participant milestones
Measure	CCTA Breast Shields Within female subset, randomization to wearing bismuth breast shield. .	CCTA No Breast Shields Within female subset, randomization to not wearing bismuth breast shield (standard of care).	Observational Non-female patients undergoing coronary CTA, patients undergoing nuclear cardiology studies and invasive coronary angiography.
Overall Study STARTED	50	51	127
Overall Study COMPLETED	49	44	127
Overall Study NOT COMPLETED	1	7	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CCTA Breast Shields n=50 Participants Within female subset, randomization to wearing bismuth breast shield.	CCTA No Breast Shields n=51 Participants Within female subset, randomization to not wearing bismuth breast shield (standard of care).	Observational Arm n=127 Participants 1\. Non-female patients undergoing coronary CTA; 2. Patients undergoing nuclear cardiology stress testing; 3. Patients undergoing invasive coronary angiography.	Total n=228 Participants Total of all reporting groups
Age, Continuous	52 years STANDARD_DEVIATION 14 • n=5 Participants	51 years STANDARD_DEVIATION 14 • n=7 Participants	51 years STANDARD_DEVIATION 12 • n=5 Participants	52 years STANDARD_DEVIATION 14 • n=4 Participants
Sex: Female, Male Female	50 Participants n=5 Participants	51 Participants n=7 Participants	92 Participants n=5 Participants	193 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	35 Participants n=5 Participants	35 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants	14 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	46 Participants n=5 Participants	48 Participants n=7 Participants	115 Participants n=5 Participants	209 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants	5 Participants n=4 Participants
BMI (kg/m^2)	27.6 kg/m^2 STANDARD_DEVIATION 6.3 • n=5 Participants	28.1 kg/m^2 STANDARD_DEVIATION 4.5 • n=7 Participants	27.3 kg/m^2 STANDARD_DEVIATION 5 • n=5 Participants	27.9 kg/m^2 STANDARD_DEVIATION 5.5 • n=4 Participants
Chest circumference (cm)	97.6 cm STANDARD_DEVIATION 11.7 • n=5 Participants	97.8 cm STANDARD_DEVIATION 10.5 • n=7 Participants	97.7 cm STANDARD_DEVIATION 11 • n=5 Participants	97.7 cm STANDARD_DEVIATION 11.1 • n=4 Participants
Current smokers	5 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants	27 Participants n=4 Participants
Heart rate (beats/min)	55.2 beats/min STANDARD_DEVIATION 5.6 • n=5 Participants	56.2 beats/min STANDARD_DEVIATION 7.4 • n=7 Participants	64 beats/min STANDARD_DEVIATION 9 • n=5 Participants	55.7 beats/min STANDARD_DEVIATION 6.6 • n=4 Participants

PRIMARY outcome

Timeframe: Change from baseline double strand DNA breaks at 30 minutes post-imaging

Population: Female patients 18 years or older who were clinically referred to undergo coronary CT angiography between August 2012 and July 2014 at Walter Reed National Military Medical Center (Bethesda, Maryland) were eligible for enrollment.

Outcome measures

Outcome measures
Measure	No Breast Shields n=49 Participants Within female subset, randomization to wearing bismuth breast shield or not wearing bismuth breast shield (standard of care). CCTA: Breast shield placement (randomized) among women.	Breast Shields n=44 Participants Within female subset, randomization to wearing bismuth breast shield or not wearing bismuth breast shield (standard of care). CCTA: Breast shield placement (randomized) among women.
Number of Excess Double-strand DNA Break Foci Per Cell in Peripheral Blood Samples Post-imaging	0.183 gamma-H2AX foci in blood lymphocytes Standard Deviation 0.114	0.159 gamma-H2AX foci in blood lymphocytes Standard Deviation 0.139

Adverse Events

CCTA Breast Shields

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

CCTA No Breast Shields

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Observational Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michael K. Cheezum, MD

Ft. Belvoir Community Hospital

Phone: 571-231-2159

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place