Coronary Heart DiseasePhase 4NCT00539604
Non Invasive Multicenter Italian Study for Coronary Artery Disease
A Phase 4 study testing MDCT and Coronary Angiography in people with Coronary Heart Disease, run by Società Italiana di Radiologia Medica at 20 sites in Italy.
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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- MDCT and Coronary Angiography
- Type of treatment
- Surgery or procedure
- How many people
- 350 participants
- Where
- 20 sitesItaly
- Study dates
- Jul 2004to Jun 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients (men or women of any ethnic group) scheduled for a coronary angiography evaluation for a diagnostic work up.
- 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).
- Patients must have HDL and total cholesterol performed within the last year.
- 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.
- Fully informed and signed consent must be obtained from each patient.
- -
Who cannot join
- Patients under 18 years of age.
- Patients who have received any investigational drug within the 30 days prior to entering this study.
- Pregnant or lactating women.
- Patients who have any contraindication to MDCT examination with iodinate contrast media.
- Patients with heart rate >70 bpm despite of β-blocker treatment (see section 8.2.4.1).
- Patients with no sinus rhythm.
Show all 10Show fewer
- Patients with NYHA III or IV class.
- Patients who have previously undergone CABG or stenting.
- Patients with a creatinine value > 2 mg/dl.
- -
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Italy20 sites
Policlinico di Bari Istituto di Radiologia
Bari, Ba, 70124
Policlinico S. Orsola Malpighi Istituto di Radiologia III
Bologna, Bo, 40138
Azienda Istituti Ospitalieri U.O. Radiologia
Cremona, CR, 26100
Ospedale G. Pasquinucci Unità Operativa di Radiologia
Massa, Ms, 54100
Ospedale San Raffaele Istituto di Radiologia
Milan, MI, 20132
Centro Cardiologico Monzino Servizio di Radiologia
Milan, MI, 20138
Policlinico di Modena Istituto di Radiologia
Modena, Mo, 41100
A.O.R.N. Cardarelli Radiologia Generale I Sez.
Naples, 80131
Policlinico P. Giaccone Dip. Scienze Radiologiche
Palermo, Pa, 90134
A.O. Riuniti Unità Operativa di Radiologia
Reggio Calabria, R.C., 89126
Policlinico Tor Vergata Istituto di Radiologia
Roma, 00133
Policlinico Umberto I Radiologia D.E.A.
Roma, 00161
Policlinico Umberto I Università degli Studi "La Sapienza" Dip. Scienze Radiologiche
Roma, 00161
Policlinico Gemelli Istituto di Radiologia
Roma, 00168
Istituti clinici Humanitas
Rozzano, Milano, 20089
Policlinico Le Scotte DAI dell' Immagine
Siena, SI, 53100
A.O. S. Maria Dipartimento di Diagnostica per Immagini
Terni, TN, 05100
Ospedale Molinette Istituto di Radiologia
Torino, To, 10126
Ospedale S. Chiara Dipartimento di Radiologia
Trento, TN, 38100
Ospedale S. Maria di Ca' Foncello U.C. Radiologia
Treviso, TV, 31100
About this study
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
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
Read the 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).
- Conditions
- Coronary Heart Disease
- Being tested
- MDCT and Coronary Angiography
- Keywords
- Comparison study between MDCT and coronary angiography
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDCT and Coronary AngiographyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (2)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2007 (estimated)
- Study startJul 2004
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 350 participants
Sponsor and investigators
- Lead sponsor
- Società Italiana di Radiologia Medica
- Sponsor type
- University, hospital or other
- Investigators
- Alessandro Del Maschio, Med. Doctor, Principal investigatorLorenzo Bonomo, Med. Doctor, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00539604
- Sponsor's protocol ID
- NIMIS-CAD
- Status last verified
- Nov 2006
- First submitted
- 3 Oct 2007
- Last updated
- 4 Oct 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00539604
- Acronym / sponsor ID
- NIMIS-CAD
- Conditions
- Coronary Heart Disease
- Keywords
- Comparison study between MDCT and coronary angiography
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants
- Lead sponsor
- Società Italiana di Radiologia MedicaUniversity, hospital or other
- Study start
- Jul 2004
- Study completion
- Jun 2006
- First posted
- 4 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients (men or women of any ethnic group) scheduled for a coronary angiography evaluation for a diagnostic work up.
- 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).
- Patients must have HDL and total cholesterol performed within the last year.
- 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.
- Fully informed and signed consent must be obtained from each patient.
Key exclusion criteria (10 listed)
- Patients under 18 years of age.
- Patients who have received any investigational drug within the 30 days prior to entering this study.
- Pregnant or lactating women.
- Patients who have any contraindication to MDCT examination with iodinate contrast media.
- Patients with heart rate >70 bpm despite of β-blocker treatment (see section 8.2.4.1).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MDCT and Coronary Angiography | Procedure or surgery | – |
Primary outcome
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
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alessandro Del Maschio, Med. Doctor principal investigator
Lorenzo Bonomo, Med. Doctor principal investigator
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MDCT and Coronary Angiography in people with Coronary Heart Disease, run by Società Italiana di Radiologia Medica at 20 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2007.