suspected or known ischemic cardiopathy MedDRA version: 14.1 Level: LLT Classification code 10055218 Term: Ischemic heart disease System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: VISIPAQUE*320MG I/ML FL 200ML
Pharmaceutical Form: Solution for injection
INN or Proposed INN: iodixanolo
CAS Number: 911211-05-7
Concentration unit: mg/l milligram(s)/litre
Concentration
Sponsors
OSPEDALE S. RAFFAELE DI MILANO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -adult patients of both sexes candidates to coronaric angio-CT for the assessment of coronary arteries for suspected or known ischemic cardiopathy - sinus rhythm - cardiac frequency less than 65 Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 110 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 140
Exclusion criteria
Exclusion criteria: -allergy to MdC iodate -renal insufficiency (creatinine >2.3 mg/dl) -patients previously revascolarized through bypass surgery aortocoronary or stent -FE30 -calcium score >400
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: validation of an experimental protocol in angioTC coronary heart disease for the reduction of contrast medium (MdC) from 20% to 60% based on modulation of the quantity of contrast and on the rate of infusion based on body mass index (BMI) of the patient.;Secondary Objective: to compare the average value of intracoronaric attenuation obtained with the two different methods;Primary end point(s): to assess the diagnostic confidence (defined as an entity of information useful for the diagnosis, obtainable with CT exam) obtained by using the experimental protocol for the reduction of the MdC, comparing it with the standard protocol of administration of a fixed volume of 80 ml of MdC.;Timepoint(s) of evaluation of this end point: 1 day | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): to compare the average value of intracoronaric attenuation obtained with the two different methods;Timepoint(s) of evaluation of this end point: 1 day | — |
Countries
Italy
Contacts
Public ContactCentro Prevenzione Cardiovascolare
Fondazione San Raffaele del Monte Tabor
Outcome results
None listed