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Phase 2 N=191 Randomized Triple-blind Diagnostic

Coronary MDCTA With Iopamidol Injection 370

Coronary Artery Disease

Bottom Line

View on ClinicalTrials.gov: NCT00558792 ↗
Enrolled (actual)
191
Serious AEs
0.0%
Results posted
Oct 2012
Primary outcome: Primary: Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 1 — 949; 842; 841 Segments Visualized Accurately — p=0.0099

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Isovue 370, 70 mL (Drug); Isovue 370, 80 mL (Drug); Isovue 370, 90 mL (Drug)
Age
Adult, Older Adult · 30+ yrs
Sex
All
Sponsor
Bracco Diagnostics, Inc
Primary completion
May 2010

Outcome Measures

OutcomeResultp-value
PRIMARY
Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 1		 949; 842; 841 0.0099 sig
PRIMARY
Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 2		 1032; 924; 927 <0.0001 sig
PRIMARY
Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 3		 925; 824; 817 0.1212
PRIMARY
Contrast Density (CD) Measurements, Off-Site Reader 1		 372.806; 398.255; 418.197 0.0200 sig
PRIMARY
Contrast Density (CD) Measurements, Off-Site Reader 2		 364.784; 396.291; 413.665 0.0044 sig
PRIMARY
Contrast Density (CD) Measurements, Off-Site Reader 3		 363.071; 383.841; 406.206 0.0371 sig
PRIMARY
Validity (Sensitivity and Specificity), Off-Site Reader 1 - Sensitivity		 63.6; 65.5; 77.8 0.2758
PRIMARY
Validity (Sensitivity and Specificity), Off-Site Reader 1 - Specificity		 98.3; 95.2; 96.6 0.2511
PRIMARY
Validity (Sensitivity and Specificity), Off-Site Reader 2 - Sensitivity		 68.2; 79.3; 66.7 0.9104
PRIMARY
Validity (Sensitivity and Specificity), Off-Site Reader 2 - Specificity		 94.5; 92.1; 90.7 0.1322
PRIMARY
Validity (Sensitivity and Specificity), Off-Site Reader 3 - Sensitivity		 59.1; 62.1; 66.7 0.5843
PRIMARY
Validity (Sensitivity and Specificity), Off-Site Reader 3 - Specificity		 94.9; 91.5; 90.7 0.0888
SECONDARY
Number of Participants Who Experienced Adverse Events With Incidence of 5% or Greater		 15; 14; 13 —

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.

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00558792). 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.

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