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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00539604 |
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Date of registration:
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03/10/2007 |
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Primary sponsor: |
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Public title:
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Non Invasive Multicenter Italian Study for Coronary Artery Disease
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Scientific title:
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Phase IV Multicenter, Intra-Individually Controlled, Comparison Study to Evaluate the Negative Predictive Value of 16-64 Slice MDCT Imaging in Patients Scheduled for Coronary Angiography |
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Date of first enrolment:
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July 2004 |
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Target sample size:
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350 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00539604 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Countries of recruitment
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Italy
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Contacts
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Name:
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Alessandro Del Maschio, Med. Doctor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Lorenzo Bonomo, Med. Doctor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Patients (men or women of any ethnic group) scheduled for a coronary angiography
evaluation for a diagnostic work up.
2. Patients will be expected to undergo coronary angiography within 2 weeks after the
MDCT study procedure. The coronary angiography must meet the minimum standard laid
down in the protocol (see section 8.3.3).
3. Patients must have HDL and total cholesterol performed within the last year.
4. Patients must be willing and able to continue study participation following the
reference test to ensure completion of all procedures and observations required by
the study.
5. Fully informed and signed consent must be obtained from each patient.
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Exclusion Criteria:
1. Patients under 18 years of age.
2. Patients who have received any investigational drug within the 30 days prior to
entering this study.
3. Pregnant or lactating women.
4. Patients who have any contraindication to MDCT examination with iodinate contrast
media.
5. Patients with heart rate >70 bpm despite of ß-blocker treatment (see section
8.2.4.1).
6. Patients with no sinus rhythm.
7. Patients with NYHA III or IV class.
8. Patients who have previously undergone CABG or stenting.
9. Patients with a creatinine value > 2 mg/dl.
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Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Coronary Heart Disease
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Intervention(s)
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Procedure: MDCT and Coronary Angiography
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Primary Outcome(s)
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to determine if 16-64 slice multidetector CT (MDCT) can replace the invasive procedure in patients scheduled for coronary angiography in order to exclude the presence of CAD
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Secondary Outcome(s)
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the efficacy in terms of performance of the MDCT in each single coronary segment and
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the safety in terms of AE related to both procedures
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Secondary ID(s)
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NIMIS-CAD
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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