Comparison of Isovue 370 vs. Standard Protocol in Coronary Computed Tomographic Angiography (CTA)

• Sponsor: Duke University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02171247
• Collaborator: (none)
• Enrollment: 35
• Arms: 2
• Duration (Months): 32

Study Details

Study Description

Brief Summary

Computed Tomography Angiogram (CTA) scans are performed routinely to look at the vessels in the body as an alternative to directly injecting contrast into the vessels and taking pictures. Different types of intravenous (into the vein, IV) contrast are available to fill the vessels and make them easier to see. The purpose of the study is to determine the best type of contrast for this scan.

Condition or Disease	Intervention/Treatment	Phase
Coronary Computed Tomographic Angiography	Drug: Isovue 370; Drug: Visipaque 320	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 35 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Diagnostic
• Official Title: Comparison of the Use of High Iodine Concentration Contrast Material (Isovue 370) vs. Standard Protocol in Coronary Computed Tomographic Angiography (CTA)
• Study Start Date: Apr 1, 2008
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Isovue 370 Isovue 370 is a contrast agent with increased iodine concentration.	Drug: Isovue 370; Isovue 370 is a contrast agent with increased iodine concentration.
Active Comparator: Visipaque 320 Standard protocol is Visipaque 320.	Drug: Visipaque 320; Visipaque 320 is standard protocol.

Outcome Measures

Primary Outcome Measures

1. Contrast to Noise Ratio [during scan, approximately 3 hours]

   Contrast-to-noise ratios (CNRs) were calculated as follows: CNR = (vascular attenuation - myocardium attenuation) / SD of mean noise attenuation.

2. Image Quality [during scan, approximately 3 hours]

   Depiction of Branch Vessels - coronary branch depiction was performed as consensus decisions of two blinded radiologists. Criteria used was abscence or presence of vessels.

3. Motion Artifact [during scan, approximately 3 hours]

   The outcome will be measured by individual scores. The scores from multiple readers will be averaged.

4. Attenuation of the Ascending Aorta and Coronary Arteries [during scan, approximately 3 hours]

   The investigator will measure the length of visualized coronary artery for the left anterior descending, left circumflex and right coronary arteries as a way of quantifying visualization of distal coronary segments.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• adult patients who are referred for coronary CTA for suspected or known coronary artery disease

Exclusion Criteria:

• creatinine greater than 2.0

• allergy to contrast media

• patients under the age of 18

• women who are pregnant or breast feeding

• patients with cardiac arrhythmia will also be excluded

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Duke University

Investigators

• Principal Investigator: Daniel T Boll, MD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT02171247
• Other Study ID Numbers: Pro00004492
• First Posted: Jun 24, 2014
• Last Update Posted: Aug 15, 2014
• Last Verified: Jul 1, 2014

• Keywords provided by Duke University: coronary computed tomographic angiography; contrast

Study Results

Participant Flow

Recruitment Details	35 subjects signed consent. 2 subjects were not assigned to a arm and were withdrawn from study due to impaired renal function. 33 subjects completed the study.

Arm/Group Title	Visipaque 320	Isovue 370
Arm/Group Description	Standard protocol is Visipaque 320. Visipaque 320: Visipaque 320 is standard protocol.	Isovue 370 is a contrast agent with increased iodine concentration. Isovue 370: Isovue 370 is a contrast agent with increased iodine concentration.
Period Title: Overall Study
STARTED	16	17
COMPLETED	16	17
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Visipaque 320	Isovue 370	Total
Arm/Group Description	Standard protocol is Visipaque 320. Visipaque 320: Visipaque 320 is standard protocol.	Isovue 370 is a contrast agent with increased iodine concentration. Isovue 370: Isovue 370 is a contrast agent with increased iodine concentration.	Total of all reporting groups
Overall Participants	16	17	33
Age, Customized (participants) [Number]
18 years and older	16 100%	17 100%	33 100%
Sex: Female, Male (Count of Participants)
Female	5 31.3%	6 35.3%	11 33.3%
Male	11 68.8%	11 64.7%	22 66.7%
Region of Enrollment (participants) [Number]
United States	16 100%	17 100%	33 100%

Outcome Measures

1. Primary Outcome

Title	Contrast to Noise Ratio
Description	Contrast-to-noise ratios (CNRs) were calculated as follows: CNR = (vascular attenuation - myocardium attenuation) / SD of mean noise attenuation.
Time Frame	during scan, approximately 3 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Visipaque 320	Isovue 370
Arm/Group Description	Standard protocol is Visipaque 320. Visipaque 320: Visipaque 320 is standard protocol.	Isovue 370 is a contrast agent with increased iodine concentration. Isovue 370: Isovue 370 is a contrast agent with increased iodine concentration.
Measure Participants	16	17
Mean (Standard Deviation) [CNR]	18.6 (5.2)	20.5 (4.5)

2. Primary Outcome

Title	Image Quality
Description	Depiction of Branch Vessels - coronary branch depiction was performed as consensus decisions of two blinded radiologists. Criteria used was abscence or presence of vessels.
Time Frame	during scan, approximately 3 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Visipaque 320	Isovue 370
Arm/Group Description	Standard protocol is Visipaque 320. Visipaque 320: Visipaque 320 is standard protocol.	Isovue 370 is a contrast agent with increased iodine concentration. Isovue 370: Isovue 370 is a contrast agent with increased iodine concentration.
Measure Participants	16	17
Conus	43.8	94.1
Sinoatrial Nodal	37.5	82.4
Diagonal1	87.5	35.3
Diagonal1 and Diagonal2	12.5	64.7
Obutse Marginal1	68.8	29.4
Obutse Marginal1 and Obutse Marginal2	6.3	70.6
Acute marginal1	62.5	47.1
Acute marginal1 and Acute marginal2	18.8	52.9
Septal perforator	43.8	88.2
Posterolateral	6.3	64.7

3. Primary Outcome

Title	Motion Artifact
Description	The outcome will be measured by individual scores. The scores from multiple readers will be averaged.
Time Frame	during scan, approximately 3 hours

Outcome Measure Data

Analysis Population Description

Data was not collected and therefore not analysed

Arm/Group Title	Visipaque 320	Isovue 370
Arm/Group Description	Standard protocol is Visipaque 320. Visipaque 320: Visipaque 320 is standard protocol.	Isovue 370 is a contrast agent with increased iodine concentration. Isovue 370: Isovue 370 is a contrast agent with increased iodine concentration.
Measure Participants	0	0

4. Primary Outcome

Title	Attenuation of the Ascending Aorta and Coronary Arteries
Description	The investigator will measure the length of visualized coronary artery for the left anterior descending, left circumflex and right coronary arteries as a way of quantifying visualization of distal coronary segments.
Time Frame	during scan, approximately 3 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Visipaque 320	Isovue 370
Arm/Group Description	Standard protocol is Visipaque 320. Visipaque 320: Visipaque 320 is standard protocol.	Isovue 370 is a contrast agent with increased iodine concentration. Isovue 370: Isovue 370 is a contrast agent with increased iodine concentration.
Measure Participants	16	17
ascending aorta	19.5 (4.8)	21.6 (4.2)
coronary arteries	18.4 (5.3)	20.3 (4.6)

Adverse Events

Arm/Group Title	Visipaque 320		Isovue 370
Arm/Group Description	Standard protocol is Visipaque 320. Visipaque 320: Visipaque 320 is standard protocol.		Isovue 370 is a contrast agent with increased iodine concentration. Isovue 370: Isovue 370 is a contrast agent with increased iodine concentration.
All Cause Mortality
	Visipaque 320		Isovue 370
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Visipaque 320		Isovue 370
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/17 (0%)
Other (Not Including Serious) Adverse Events
	Visipaque 320		Isovue 370
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/17 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.