Clinical trial NCT00539604: Non Invasive Multicenter Italian Study for Coronary Artery Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Heart Disease
Keywords: Comparison study between MDCT and coronary angiography
Lead sponsor: Società Italiana di Radiologia Medica
Sponsor class: OTHER
First posted: 2007-10-04
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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

Detailed description: Because coronary artery disease (CAD) is the most frequent cause of death in industrialized nations and its onset is currently unpredictable, there is a need for new methods of screening apparently healthy individuals to identify those at increased risk.

Several imaging techniques are in use to visualize coronary arteries. These include both invasive procedure as x-ray coronary angiography and those non invasive like computed tomography (CT) and magnetic resonance imaging (MRI). Among these imaging modalities, selective cardiac catheterization and x-ray angiography is the current gold standard for visualization of coronaries and detection of their stenoses, providing for optimal spatial resolution, a general "road map" of the coronary tree for interventions. The replacement of even a fraction of these procedures with non-invasive modalities would constitute an important advance in the care of patients with suspected coronary artery disease Preliminary results reported in literature addressing the study of coronary arteries by multidetector-CT (MDCT) appear to be interesting. Several studies have been performed firstly using Electron beam CT (EBCT).EBCT provides high temporal resolution and enables quantitative assessment of the coronary artery calcium, but because of limited spatial resolution as a result of limited z axis resolution, it does not permit direct visualisation in multi-reformation of the whole coronary artery system.

With the introduction of 4-row MDCT there have now been several studies aimed to compare the MDCT with a standard invasive angiography. Data published for over 200 subjects from 4 studies demonstrated that patient compliance at breath-hold, heart rate and rhythm are crucial limitation to this procedure. In the Nieman and Achembach papers not all the coronary segments were assessable because of the limited temporal resolution of 4-slice MDCT. With this machine it is mandatory to select patients carefully, considering only those with baseline hearth rate \< 65 bpm (also obtained by pre-treatment with β-blockers in order to slow hearth rate).

Eligibility criteria: 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 β-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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Primary outcomes:
measure: 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
Secondary outcomes:
measure: the efficacy in terms of performance of the MDCT in each single coronary segment and
measure: the safety in terms of AE related to both procedures
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Policlinico di Bari Istituto di Radiologia
state: Ba
city: Bologna
country: Italy
facility: Policlinico S. Orsola Malpighi Istituto di Radiologia III
state: Bo
city: Cremona
country: Italy
facility: Azienda Istituti Ospitalieri U.O. Radiologia
state: CR
city: Rozzano
country: Italy
facility: Istituti clinici Humanitas
state: Milano
city: Milano
country: Italy
facility: Ospedale San Raffaele Istituto di Radiologia
state: MI
city: Milano
country: Italy
facility: Centro Cardiologico Monzino Servizio di Radiologia
state: MI
city: Modena
country: Italy
facility: Policlinico di Modena Istituto di Radiologia
state: Mo
city: Massa
country: Italy
facility: Ospedale G. Pasquinucci Unità Operativa di Radiologia
state: Ms
city: Palermo
country: Italy
facility: Policlinico P. Giaccone Dip. Scienze Radiologiche
state: Pa
city: Reggio Calabria
country: Italy
facility: A.O. Riuniti Unità Operativa di Radiologia
state: R.c.
city: Siena
country: Italy
facility: Policlinico Le Scotte DAI dell' Immagine
state: SI
city: Terni
country: Italy
facility: A.O. S. Maria Dipartimento di Diagnostica per Immagini
state: TN
city: Trento
country: Italy
facility: Ospedale S. Chiara Dipartimento di Radiologia
state: TN
city: Torino
country: Italy
facility: Ospedale Molinette Istituto di Radiologia
state: To
city: Treviso
country: Italy
facility: Ospedale S. Maria di Ca' Foncello U.C. Radiologia
state: TV
city: Napoli
country: Italy
facility: A.O.R.N. Cardarelli Radiologia Generale I Sez.
city: Roma
country: Italy
facility: Policlinico Tor Vergata Istituto di Radiologia
city: Roma
country: Italy
facility: Policlinico Umberto I Radiologia D.E.A.
city: Roma
country: Italy
facility: Policlinico Umberto I Università degli Studi "La Sapienza" Dip. Scienze Radiologiche
city: Roma
country: Italy
facility: Policlinico Gemelli Istituto di Radiologia
Study officials:
name: Alessandro Del Maschio, Med. Doctor
role: PRINCIPAL_INVESTIGATOR
name: Lorenzo Bonomo, Med. Doctor
role: PRINCIPAL_INVESTIGATOR
References: