Patients who have known or suspected CAD and suspected significant (> 50%) coronary artery stenosis MedDRA version: 9.1 Level: LLT Classification code 10011089 Term: Coronary artery stenosis
Conditions
Interventions
Trade Name: IOPAMIRO 370
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Iopamidol
Concentration unit: ml millilitre(s)
Concentration type: equal
Concentration number: 90-
Sponsors
BRACCO IMAGING
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Enroll patients in this study if they meet the following protocol requirements: Can provide written informed consent and are willing to comply with protocol requirements; Are at least 30 years of age;, and weigh less than 250 pounds (113.6 kg); Are known or suspected to have CAD, and are suspected to have significant (>50%) coronary artery stenosis; Are scheduled to undergo coronary angiography within 2 weeks of the MDCTA scan; Are able to undergo coronary MDCTA scanning; Have an Agatston calcification score21 of =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A patient will be excluded from the study if he/she does not fulfill the inclusion criteria or if any of the following are observed: Has a history of hypersensitivity to iodinated contrast agents; Has known or suspected hyperthyroidism or pheochromocytoma; Has renal impairment (eGFR <60 mL/min/1.73 m2, calculated using the Modification of Diet in Renal Disease [MDRD] study equation , ); Has a prior history of coronary arterial stent implantation and/or prior coronary artery bypass grafting; Has atrial fibrillation or any other cardiac rhythm that precludes reliable ECG triggering; Has severe congestive heart failure, New York Heart Classification (NYHA) Class IV (Appendix A); Has an unstable cardiac condition, including acute coronary syndrome or acute myocardial infarction, that may alter the status of coronary disease between the time of MDCTA and that of conventional coronary angiography; Has received an iodinated contrast agent within 7 days prior to the administration of the investigational product or is scheduled to receive one within 24 hours after investigational product administration other than for the related coronary angiography procedure; Is a pregnant or lactating female. Exclude the possibility of pregnancy by: Laboratory testing on-site at the testing institution (measurement of serum or urine beta-HCG) within 24 hours prior to investigational product administration; History (e.g., tubal ligation, hysterectomy or post-menopausal with a minimum of 1 year without menses); Was previously entered into this study or received an investigational compound within 30 days before admission into this study; Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the dose of iopamidol injection 370 to be used in future Phase III clinical testing when used for coronary MDCTA by assessing 3 different volumes , i.e., 70, 80, 90 mL;Secondary Objective: To obtain additional information about the safety of iopamidol injection 370 in patients with known or suspected CAD undergoing coronary MDCTA.;Primary end point(s): Identification of coronary arteries containing significant stenoses dy MDCTA. | — |
Countries
Italy
Outcome results
None listed