Coronary Plaque Lipid CharacterizationMIRACLENCT00558441
Prospective Data Collection of IVMRI Cases
A study testing IVMRI in people with Coronary Plaque Lipid Characterization, run by TopSpin Medical at 1 site in Israel.
Trial summary
The study purpose is to prospectively collect data for a set of predefined variables in clinical cases where coronary plaque lipid characterization by IVMRI was performed during diagnostic or interventional procedures in order to gather incremental information beyond angiography and other diagnostic modalities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Plaque Lipid Characterization
- What is being tested?
- IVMRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2007to Nov 2013
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- An adult patient ≥ 18 years old.
- The patient, or legal guardian, has been informed of the nature of the study, agrees to its provisions, and has sign the approved informed consent.
- The patient and the treating physician agree to attend the follow-ups as defined in the study protocol.
- Indication for diagnostic and/or interventional procedure.
- Lesions in a native vessels where IVMRI interrogation may provide additional information beyond angiography and other diagnostic tools.
Who cannot join
- Culprit lesions within 48 hours following STEMI.
- Tortuous vessels, calcified or thrombotic lesions.
- Significant stenosis of an unprotected left main coronary artery.
- IVMRI interrogation of an unprotected left main coronary artery.
- Patients with pacemaker or cardioverter defibrillator.
- The patient is suffering from transplant mediated coronary artery disease.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Sourasky Medical Center
Tel Aviv
Shmuel Banai, Prof., +972-3-6973395, shmuelb@tasmc.health.gov.il
Shmuel Banai, Prof.
About this study
Official title: Prospective Data Collection in Clinical Cases Where Coronary Plaque Lipid Characterization by IVMRI Was Performed During Diagnostic or Interventional Catheterization Procedures
The study purpose is to prospectively collect data for a set of predefined variables in clinical cases where coronary plaque lipid characterization by IVMRI was performed during diagnostic or interventional procedures in order to gather incremental information beyond angiography and other diagnostic modalities.
- Conditions
- Coronary Plaque Lipid Characterization
- Being tested
- IVMRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVMRIDevice
Also called Cathamaran
Intra Vascular Magnetic Resonance Imaging
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Device: IVMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
LFI - Lipid Fraction Index
Measured: 5 years
Secondary outcomes (1)
correlation between LFI and a set of predefined parameters
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2007 (estimated)
- Study startNov 2007
- Study completionNov 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Plaque Lipid CharacterizationStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TopSpin Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- William Wijns, Prof., Principal investigator, OLV Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00558441
- Sponsor's protocol ID
- PCL-1.2-002
- Acronym
- MIRACLE
- Status last verified
- Nov 2007
- First submitted
- 14 Nov 2007
- Last updated
- 15 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Data Collection in Clinical Cases Where Coronary Plaque Lipid Characterization by IVMRI Was Performed During Diagnostic or Interventional Catheterization Procedures
- ClinicalTrials.gov ID
- NCT00558441
- Acronym / sponsor ID
- MIRACLE / PCL-1.2-002
- Conditions
- Coronary Plaque Lipid Characterization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- TopSpin MedicalIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Study completion
- Nov 2013 (estimated)
- First posted
- 15 Nov 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.
The study purpose is to prospectively collect data for a set of predefined variables in clinical cases where coronary plaque lipid characterization by IVMRI was performed during diagnostic or interventional procedures in order to gather incremental information beyond angiography and other diagnostic modalities.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: IVMRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- An adult patient ≥ 18 years old.
- The patient, or legal guardian, has been informed of the nature of the study, agrees to its provisions, and has sign the approved informed consent.
- The patient and the treating physician agree to attend the follow-ups as defined in the study protocol.
- Indication for diagnostic and/or interventional procedure.
- Lesions in a native vessels where IVMRI interrogation may provide additional information beyond angiography and other diagnostic tools.
Key exclusion criteria (6 listed)
- Culprit lesions within 48 hours following STEMI.
- Tortuous vessels, calcified or thrombotic lesions.
- Significant stenosis of an unprotected left main coronary artery.
- IVMRI interrogation of an unprotected left main coronary artery.
- Patients with pacemaker or cardioverter defibrillator.
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 |
|---|---|---|
| IVMRIAlso: CathamaranIntra Vascular Magnetic Resonance Imaging | Device | 1 |
Primary outcome
LFI - Lipid Fraction Index
Time frame: 5 years
1 secondary outcome
correlation between LFI and a set of predefined parameters
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2007.
Related trials for Coronary Plaque Lipid Characterization
RecruitingObservational study
Identification of Lesion Characteristics in Coronary Plaques Using Multimodality Intravascular Imaging and Novel Photon-counting CT in Stable Angina
Coronary Artery Disease (CAD), Stable Angina Pectoris
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.
William Wijns, Prof. principal investigator
OLV Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IVMRI in people with Coronary Plaque Lipid Characterization, run by TopSpin Medical at 1 site in Israel.
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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 15 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sharon Sax (+972-54-6603112, sharons@topspin.co.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LFI - Lipid Fraction Index (time frame: 5 years). 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 15 Nov 2007.