Non Invasive Multicenter Italian Study for Coronary Artery Disease

This study has been completed.
Sponsor:
Information provided by:
Società Italiana di Radiologia Medica
ClinicalTrials.gov Identifier:
NCT00539604
First received: October 3, 2007
Last updated: NA
Last verified: November 2006
History: No changes posted
  Purpose

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 Intervention Phase
Coronary Heart Disease
Procedure: MDCT and Coronary Angiography
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by Società Italiana di Radiologia Medica:

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

Estimated Enrollment: 350
Study Start Date: July 2004
Estimated Study Completion Date: June 2006
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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00539604

Locations
Italy
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
Centro Cardiologico Monzino Servizio di Radiologia
Milano, MI, Italy, 20138
Ospedale San Raffaele Istituto di Radiologia
Milano, MI, Italy, 20132
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 Umberto I Università degli Studi "La Sapienza" Dip. Scienze Radiologiche
Roma, Italy, 00161
Policlinico Gemelli Istituto di Radiologia
Roma, Italy, 00168
Policlinico Tor Vergata Istituto di Radiologia
Roma, Italy, 00133
Policlinico Umberto I Radiologia D.E.A.
Roma, Italy, 00161
Sponsors and Collaborators
Società Italiana di Radiologia Medica
Investigators
Principal Investigator: Alessandro Del Maschio, Med. Doctor
Principal Investigator: Lorenzo Bonomo, Med. Doctor
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00539604     History of Changes
Other Study ID Numbers: NIMIS-CAD
Study First Received: October 3, 2007
Last Updated: October 3, 2007
Health Authority: Italy: Ethics Committee

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

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

ClinicalTrials.gov processed this record on September 18, 2014