Coronary Artery DiseasePhase 2NCT00558792

Coronary MDCTA With Iopamidol Injection 370

A Phase 2 study testing Isovue 370, 70 mL, Isovue 370, 80 mL and Isovue 370, 90 mL in people with Coronary Artery Disease, run by Bracco Diagnostics, Inc at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Determine the validity and compare the visualization of arterial segments obtained with 3 doses of iopamidol to determine dose for further investigation in future trials. Read more about this study

Who is it for?: Ages 30 years and older
Conditions the study is for: Coronary Artery Disease
What is being tested?: Isovue 370, 70 mL, Isovue 370, 80 mL and Isovue 370, 90 mL
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 210 participants
Where: 1 siteUnited States
Study dates: Nov 2007to May 2010
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Provide informed consent
At least 30 years of age
Weight less than 250 lbs
Known or suspected coronary artery disease and suspected to have significant coronary artery stenosis
Undergo MDCTA scan
Undergo coronary angiography within 2 weeks of MDCTA scan

Who cannot join

Hx of hypersensitivity to iodinated contrast agents
Known or suspected hyperthyroidism or pheochromocytoma
Renal impairment
History of coronary artery stent placement or bypass grafts
Unstable
Pregnant or lactating

Trial locations and contacts

1 site in 1 country.

United States1 site

Bracco Diagnostics
Princeton, New Jersey, 08540

Other trials in United States

About this study

Official title: A Phase II Multicenter Randomized Double Blind Dose Finding Study of Iopamidol Injection 370 in Multidetector Computed Tomographic Angiography (MDCTA) in Patients With Suspected Coronary Artery Stenosis

Determine the validity and compare the visualization of arterial segments obtained with 3 doses of iopamidol to determine dose for further investigation in future trials.

Conditions: Coronary Artery Disease
Being tested: Isovue 370, 70 mL, Isovue 370, 80 mL, Isovue 370, 90 mL
Medical subject headings: Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Isovue 370, 70 mLDrug
Also called Isovue
70 mL of iopamidol injection 370 injected at a rate of >=4 mL/second
Isovue 370, 80 mLDrug
Also called Isovue
80 mL of iopamidol injection 370 injected at a rate of >=4 mL/second
Isovue 370, 90 mLDrug
Also called Isovue
90 mL of iopamidol injection 370 injected at a rate of >=4 mL/second

Study groups in NCT00558792
Study group	Role	What they receive
Isovue 370, 70 mL	Experimental	iopamidol injection 370, 70 mL Receives: Drug: Isovue 370, 70 mL
Isovue 370, 80 mL	Experimental	iopamidol injection 370, 80 mL Receives: Drug: Isovue 370, 80 mL
Isovue 370, 90 mL	Experimental	iopamidol injection 370, 90 mL Receives: Drug: Isovue 370, 90 mL

What is being measured

The primary outcome is the main question the study is designed to answer.

Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 1
For all technically adequate coronary artery segments, each reader was to assess whether each segment was visualized to a quality that was adequate for accurate diagnosis of the presence and severity of stenosis. An adequate quality for the accurate diagnosis of the presence and severity of coronary artery stenosis was comprised of 2 basic features: 1) no more than mild blurring of the spatial distinction between the vessel wall and lumen, and 2) a readily visible distinction in image contrast between calcified plaque, enhanced vessel lumen, and uncalcified vessel wall or plaque.
Measured: Immediately post dose
Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 2
For all technically adequate coronary artery segments, each reader was to assess whether each segment was visualized to a quality that was adequate for accurate diagnosis of the presence and severity of stenosis. An adequate quality for the accurate diagnosis of the presence and severity of coronary artery stenosis was comprised of 2 basic features: 1) no more than mild blurring of the spatial distinction between the vessel wall and lumen, and 2) a readily visible distinction in image contrast between calcified plaque, enhanced vessel lumen, and uncalcified vessel wall or plaque.
Measured: Immediately post dose
Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 3
For all technically adequate coronary artery segments, each reader was to assess whether each segment was visualized to a quality that was adequate for accurate diagnosis of the presence and severity of stenosis. An adequate quality for the accurate diagnosis of the presence and severity of coronary artery stenosis was comprised of 2 basic features: 1) no more than mild blurring of the spatial distinction between the vessel wall and lumen, and 2) a readily visible distinction in image contrast between calcified plaque, enhanced vessel lumen, and uncalcified vessel wall or plaque.
Measured: Immediately post dose
Contrast Density (CD) Measurements, Off-Site Reader 1
For this assessment, each off-site reader was to place regions of interest (ROIs) into the lumens of the mid-portion of the left main coronary artery (LM) (segment number 5), and into the mid-portion of segment number 1 of the right coronary artery (RCA). The mean Hounsfield Units levels and standard deviations (SD) for those 2 ROIs were to be recorded by the reader.
Measured: Immediately post dose
Contrast Density (CD) Measurements, Off-Site Reader 2
For this assessment, each off-site reader was to place regions of interest (ROIs) into the lumens of the mid-portion of the left main coronary artery (LM) (segment number 5), and into the mid-portion of segment number 1 of the right coronary artery (RCA). The mean Hounsfield Units levels and standard deviations (SD) for those 2 ROIs were to be recorded by the reader.
Measured: Immediately post dose
Contrast Density (CD) Measurements, Off-Site Reader 3
For this assessment, each off-site reader was to place regions of interest (ROIs) into the lumens of the mid-portion of the left main coronary artery (LM) (segment number 5), and into the mid-portion of segment number 1 of the right coronary artery (RCA). The mean Hounsfield Units levels and standard deviations (SD) for those 2 ROIs were to be recorded by the reader.
Measured: Immediately post dose
Validity (Sensitivity and Specificity), Off-Site Reader 1 - Sensitivity
For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of sensitivity [TP/(TP+FN)] is presented.
Measured: Immediately post dose
Validity (Sensitivity and Specificity), Off-Site Reader 1 - Specificity
For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of specificity [TN/(TN+FP)] is presented.
Measured: Immediately post dose
Validity (Sensitivity and Specificity), Off-Site Reader 2 - Sensitivity
For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of sensitivity [TP/(TP+FN)] is presented.
Measured: Immediately post dose
Validity (Sensitivity and Specificity), Off-Site Reader 2 - Specificity
For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of specificity [TN/(TN+FP)] is presented.
Measured: Immediately post dose
Validity (Sensitivity and Specificity), Off-Site Reader 3 - Sensitivity
For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of sensitivity [TP/(TP+FN)] is presented.
Measured: Immediately post dose
Validity (Sensitivity and Specificity), Off-Site Reader 3 - Specificity
For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of specificity [TN/(TN+FP)] is presented.
Measured: Immediately post dose

Secondary outcomes (1)

Number of Participants Who Experienced Adverse Events With Incidence of 5% or Greater
Participants who received investigational product (iopamidol injection) and experienced an adverse event (AE). See Adverse Events module for further details.
Measured: up to 72 hours post dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2007May 2010

First posted15 Nov 2007 (estimated)
Study startNov 2007
Primary completionMay 2010
Study completionMay 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 210 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00558792
Sponsor's protocol ID: IOP 108
Other IDs: NCT00558792
Status last verified: Oct 2012
First submitted: 13 Nov 2007
Last updated: 24 Oct 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingObservational study
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RecruitingObservational study
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All Coronary Artery Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Multicenter Randomized Double Blind Dose Finding Study of Iopamidol Injection 370 in Multidetector Computed Tomographic Angiography (MDCTA) in Patients With Suspected Coronary Artery Stenosis
ClinicalTrials.gov ID: NCT00558792
Acronym / sponsor ID: IOP 108
Conditions: Coronary Artery Disease
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 210 participants (actual)
Lead sponsor: Bracco Diagnostics, IncIndustry (pharma, biotech, devices)
Study start: Nov 2007
Primary completion: May 2010 (actual)
Study completion: May 2010 (actual)
First posted: 15 Nov 2007 (estimated)
Results: Posted 19 Oct 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Determine the validity and compare the visualization of arterial segments obtained with 3 doses of iopamidol to determine dose for further investigation in future trials.

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Isovue 370, 70 mL	Experimental	Drug: Isovue 370, 70 mLiopamidol injection 370, 70 mL
Isovue 370, 80 mL	Experimental	Drug: Isovue 370, 80 mLiopamidol injection 370, 80 mL
Isovue 370, 90 mL	Experimental	Drug: Isovue 370, 90 mLiopamidol injection 370, 90 mL

Who may qualify

Ages: 30 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Provide informed consent
At least 30 years of age
Weight less than 250 lbs
Known or suspected coronary artery disease and suspected to have significant coronary artery stenosis
Undergo MDCTA scan

Key exclusion criteria (6 listed)

Hx of hypersensitivity to iodinated contrast agents
Known or suspected hyperthyroidism or pheochromocytoma
Renal impairment
History of coronary artery stent placement or bypass grafts
Unstable

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Isovue 370, 70 mLAlso: Isovue70 mL of iopamidol injection 370 injected at a rate of >=4 mL/second	Drug	Isovue 370, 70 mL
Isovue 370, 80 mLAlso: Isovue80 mL of iopamidol injection 370 injected at a rate of >=4 mL/second	Drug	Isovue 370, 80 mL
Isovue 370, 90 mLAlso: Isovue90 mL of iopamidol injection 370 injected at a rate of >=4 mL/second	Drug	Isovue 370, 90 mL

Primary outcome

Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 1
Time frame: Immediately post dose
For all technically adequate coronary artery segments, each reader was to assess whether each segment was visualized to a quality that was adequate for accurate diagnosis of the presence and severity of stenosis. An adequate quality for the accurate diagnosis of the presence and severity of coronary artery stenosis was comprised of 2 basic features: 1) no more than mild blurring of the spatial distinction between the vessel wall and lumen, and 2) a readily visible distinction in image contrast between calcified plaque, enhanced vessel lumen, and uncalcified vessel wall or plaque.
Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 2
Time frame: Immediately post dose
For all technically adequate coronary artery segments, each reader was to assess whether each segment was visualized to a quality that was adequate for accurate diagnosis of the presence and severity of stenosis. An adequate quality for the accurate diagnosis of the presence and severity of coronary artery stenosis was comprised of 2 basic features: 1) no more than mild blurring of the spatial distinction between the vessel wall and lumen, and 2) a readily visible distinction in image contrast between calcified plaque, enhanced vessel lumen, and uncalcified vessel wall or plaque.
Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 3
Time frame: Immediately post dose
For all technically adequate coronary artery segments, each reader was to assess whether each segment was visualized to a quality that was adequate for accurate diagnosis of the presence and severity of stenosis. An adequate quality for the accurate diagnosis of the presence and severity of coronary artery stenosis was comprised of 2 basic features: 1) no more than mild blurring of the spatial distinction between the vessel wall and lumen, and 2) a readily visible distinction in image contrast between calcified plaque, enhanced vessel lumen, and uncalcified vessel wall or plaque.
Contrast Density (CD) Measurements, Off-Site Reader 1
Time frame: Immediately post dose
For this assessment, each off-site reader was to place regions of interest (ROIs) into the lumens of the mid-portion of the left main coronary artery (LM) (segment number 5), and into the mid-portion of segment number 1 of the right coronary artery (RCA). The mean Hounsfield Units levels and standard deviations (SD) for those 2 ROIs were to be recorded by the reader.
Contrast Density (CD) Measurements, Off-Site Reader 2
Time frame: Immediately post dose
For this assessment, each off-site reader was to place regions of interest (ROIs) into the lumens of the mid-portion of the left main coronary artery (LM) (segment number 5), and into the mid-portion of segment number 1 of the right coronary artery (RCA). The mean Hounsfield Units levels and standard deviations (SD) for those 2 ROIs were to be recorded by the reader.
Contrast Density (CD) Measurements, Off-Site Reader 3
Time frame: Immediately post dose
For this assessment, each off-site reader was to place regions of interest (ROIs) into the lumens of the mid-portion of the left main coronary artery (LM) (segment number 5), and into the mid-portion of segment number 1 of the right coronary artery (RCA). The mean Hounsfield Units levels and standard deviations (SD) for those 2 ROIs were to be recorded by the reader.
Validity (Sensitivity and Specificity), Off-Site Reader 1 - Sensitivity
Time frame: Immediately post dose
For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of sensitivity [TP/(TP+FN)] is presented.
Validity (Sensitivity and Specificity), Off-Site Reader 1 - Specificity
Time frame: Immediately post dose
For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of specificity [TN/(TN+FP)] is presented.
Validity (Sensitivity and Specificity), Off-Site Reader 2 - Sensitivity
Time frame: Immediately post dose
For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of sensitivity [TP/(TP+FN)] is presented.
Validity (Sensitivity and Specificity), Off-Site Reader 2 - Specificity
Time frame: Immediately post dose
For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of specificity [TN/(TN+FP)] is presented.
Validity (Sensitivity and Specificity), Off-Site Reader 3 - Sensitivity
Time frame: Immediately post dose
For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of sensitivity [TP/(TP+FN)] is presented.
Validity (Sensitivity and Specificity), Off-Site Reader 3 - Specificity
Time frame: Immediately post dose
For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of specificity [TN/(TN+FP)] is presented.

1 secondary outcome

Number of Participants Who Experienced Adverse Events With Incidence of 5% or Greater
Time frame: up to 72 hours post dose

Results and safety

Results posted to the registry on 19 Oct 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Isovue 370, 70 mL	68	68
Isovue 370, 80 mL	63	63
Isovue 370, 90 mL	60	60

Primary outcome: Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 1

Time frame: Immediately post dose. Number. Unit: Segments Visualized Accurately

Measure	Isovue 370, 70 mL n = 68	Isovue 370, 80 mL n = 62	Isovue 370, 90 mL n = 60
Value	949	842	841

Isovue 370, 70 mL vs Isovue 370, 80 mL vs Isovue 370, 90 mL: p = 0.0099, Chi-squared

Primary outcome: Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 2

Time frame: Immediately post dose. Number. Unit: Segments Visualized Accurately

Measure	Isovue 370, 70 mL n = 68	Isovue 370, 80 mL n = 62	Isovue 370, 90 mL n = 60
Value	1032	924	927

Isovue 370, 70 mL vs Isovue 370, 80 mL vs Isovue 370, 90 mL: p <0.0001, Chi-squared

Primary outcome: Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 3

Time frame: Immediately post dose. Number. Unit: Segments Visualized Accurately

Measure	Isovue 370, 70 mL n = 68	Isovue 370, 80 mL n = 62	Isovue 370, 90 mL n = 60
Value	925	824	817

Isovue 370, 70 mL vs Isovue 370, 80 mL vs Isovue 370, 90 mL: p = 0.1212, Chi-squared

Primary outcome: Contrast Density (CD) Measurements, Off-Site Reader 1

Time frame: Immediately post dose. Mean (Standard Deviation). Unit: Hounsfield Units

Measure	Isovue 370, 70 mL n = 67	Isovue 370, 80 mL n = 58	Isovue 370, 90 mL n = 59
Value	372.806 (90.5842)	398.255 (82.3593)	418.197 (97.4072)

Isovue 370, 70 mL vs Isovue 370, 80 mL vs Isovue 370, 90 mL: p = 0.0200, ANOVA

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Patients were monitored for any untoward medical occurrence from the time they signed the informed consent until 72 hours after the administration of iopamidol injection 370.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Isovue 370, 70 mL	0 of 68 (0%)	15 of 68 (22.1%)	Not reported
Isovue 370, 80 mL	0 of 63 (0%)	14 of 63 (22.2%)	Not reported
Isovue 370, 90 mL	0 of 60 (0%)	13 of 60 (21.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jiefen Yao, M.D. study director

Bracco Diagnostics, Inc

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Isovue 370, 70 mL, Isovue 370, 80 mL and Isovue 370, 90 mL in people with Coronary Artery Disease, run by Bracco Diagnostics, Inc at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 1 (time frame: Immediately post dose). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00558792.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2012.