Non Invasive Multicenter Italian Study for Coronary Artery Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00539604
Recruitment Status : Completed
First Posted : October 4, 2007
Last Update Posted : October 4, 2007
Information provided by:
Società Italiana di Radiologia Medica

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

Condition or disease Intervention/treatment Phase
Coronary Heart Disease Procedure: MDCT and Coronary Angiography Phase 4

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).

Study Type : Interventional  (Clinical Trial)
Enrollment : 350 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : July 2004
Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. the efficacy in terms of performance of the MDCT in each single coronary segment and
  2. the safety in terms of AE related to both procedures

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 β-blocker treatment (see section
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00539604

Policlinico di Bari Istituto di Radiologia
Bari, Ba, Italy, 70124
Policlinico S. Orsola Malpighi Istituto di Radiologia III
Bologna, Bo, Italy, 40138
Azienda Istituti Ospitalieri U.O. Radiologia
Cremona, CR, Italy, 26100
Istituti clinici Humanitas
Rozzano, Milano, Italy, 20089
Ospedale San Raffaele Istituto di Radiologia
Milano, MI, Italy, 20132
Centro Cardiologico Monzino Servizio di Radiologia
Milano, MI, Italy, 20138
Policlinico di Modena Istituto di Radiologia
Modena, Mo, Italy, 41100
Ospedale G. Pasquinucci Unità Operativa di Radiologia
Massa, Ms, Italy, 54100
Policlinico P. Giaccone Dip. Scienze Radiologiche
Palermo, Pa, Italy, 90134
A.O. Riuniti Unità Operativa di Radiologia
Reggio Calabria, R.c., Italy, 89126
Policlinico Le Scotte DAI dell' Immagine
Siena, SI, Italy, 53100
A.O. S. Maria Dipartimento di Diagnostica per Immagini
Terni, TN, Italy, 05100
Ospedale S. Chiara Dipartimento di Radiologia
Trento, TN, Italy, 38100
Ospedale Molinette Istituto di Radiologia
Torino, To, Italy, 10126
Ospedale S. Maria di Ca' Foncello U.C. Radiologia
Treviso, TV, Italy, 31100
A.O.R.N. Cardarelli Radiologia Generale I Sez.
Napoli, Italy, 80131
Policlinico Tor Vergata Istituto di Radiologia
Roma, Italy, 00133
Policlinico Umberto I Radiologia D.E.A.
Roma, Italy, 00161
Policlinico Umberto I Università degli Studi "La Sapienza" Dip. Scienze Radiologiche
Roma, Italy, 00161
Policlinico Gemelli Istituto di Radiologia
Roma, Italy, 00168
Sponsors and Collaborators
Società Italiana di Radiologia Medica
Principal Investigator: Alessandro Del Maschio, Med. Doctor
Principal Investigator: Lorenzo Bonomo, Med. Doctor Identifier: NCT00539604     History of Changes
Other Study ID Numbers: NIMIS-CAD
First Posted: October 4, 2007    Key Record Dates
Last Update Posted: October 4, 2007
Last Verified: November 2006

Keywords provided by Società Italiana di Radiologia Medica:
Comparison study between MDCT and coronary angiography

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases