Non Invasive Multicenter Italian Study for Coronary Artery Disease

Coronary Heart Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00539604
• Other study ID #: NIMIS-CAD
• Status: Completed
• Phase: Phase 4
• First received: October 3, 2007
• Last updated: October 3, 2007
• Start date: July 2004
• Est. completion date: June 2006

Study information

• Verified date: November 2006
• Source: Società Italiana di Radiologia Medica
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Myocardial Ischemia

Intervention

Procedure:
• MDCT and Coronary Angiography

Locations

Country	Name	City	State
Italy	Policlinico di Bari Istituto di Radiologia	Bari	Ba
Italy	Policlinico S. Orsola Malpighi Istituto di Radiologia III	Bologna	Bo
Italy	Azienda Istituti Ospitalieri U.O. Radiologia	Cremona	CR
Italy	Ospedale G. Pasquinucci Unità Operativa di Radiologia	Massa	Ms
Italy	Centro Cardiologico Monzino Servizio di Radiologia	Milano	MI
Italy	Ospedale San Raffaele Istituto di Radiologia	Milano	MI
Italy	Policlinico di Modena Istituto di Radiologia	Modena	Mo
Italy	A.O.R.N. Cardarelli Radiologia Generale I Sez.	Napoli
Italy	Policlinico P. Giaccone Dip. Scienze Radiologiche	Palermo	Pa
Italy	A.O. Riuniti Unità Operativa di Radiologia	Reggio Calabria	R.c.
Italy	Policlinico Gemelli Istituto di Radiologia	Roma
Italy	Policlinico Tor Vergata Istituto di Radiologia	Roma
Italy	Policlinico Umberto I Radiologia D.E.A.	Roma
Italy	Policlinico Umberto I Università degli Studi "La Sapienza" Dip. Scienze Radiologiche	Roma
Italy	Istituti clinici Humanitas	Rozzano	Milano
Italy	Policlinico Le Scotte DAI dell' Immagine	Siena	SI
Italy	A.O. S. Maria Dipartimento di Diagnostica per Immagini	Terni	TN
Italy	Ospedale Molinette Istituto di Radiologia	Torino	To
Italy	Ospedale S. Chiara Dipartimento di Radiologia	Trento	TN
Italy	Ospedale S. Maria di Ca' Foncello U.C. Radiologia	Treviso	TV

Sponsors (1)

Lead Sponsor	Collaborator
Società Italiana di Radiologia Medica

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	the efficacy in terms of performance of the MDCT in each single coronary segment and
Secondary	the safety in terms of AE related to both procedures