Coronary Artery DiseaseRECRUITNCT01346605
Registry for CARDIAC PERFUSION CT
An observational study of Coronary Artery Disease, run by MDDX LLC at 1 site in United States.
Trial summary
This protocol describes a study whose goal is to collect de-identified Cardiac CT Perfusion (CTP) acquisition parameters and clinical findings from approximately 20 qualified medical facilities. The study uses an electronic data capture tool to collect the de-identified data to create a global multi-center registry. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Aug 2012
- Phase
- Observational
- 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 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Prior stress SPECT with intermediate to high likelihood to be referred to the cardiac catheterization laboratory for an invasive coronary angiogram or patients presenting with chest pain and clinical indication of Coronary CT Angiography and an initial calcium score above 300
Who may be able to join
- Moderate-high likelihood of coronary artery disease with a prior stress SPECTMPI exam likely to be referred to the cardiac catheterization laboratory for invasive angiogram or patients presenting with clinical indication of Coronary -CT Angiography and an initial calcium score above 300
- Stable angina or anginal equivalent as the chief symptom.
- Age > 34 years old
- Able to comprehend and sign the consent form.
Who cannot join
- BMI<41
- Acute coronary syndromes (unstable angina, non-ST elevation myocardial infarction, ST elevation myocardial infarction)
- Unstable clinical conditions (i.e. hemodynamic instability, arrhythmias)
- Premenopausal women who have menstruated in the last year
- Glomerular Filtration Rate (GFR) < 60 ml/min/BSA as an indicator of renal insufficiency
- Known allergy to iodinated contrast agents
Show all 13Show fewer
- Patients who are on metformin medication for any reason
- Atrial fibrillation
- Asthma
- Critical aortic stenosis
- Systolic blood pressure < 90 mmHg
- Advanced heart block
- Pacemaker or AICD
Trial locations and contacts
1 site in 1 country.
About this study
This protocol describes a study whose goal is to collect de-identified Cardiac CT Perfusion (CTP) acquisition parameters and clinical findings from approximately 20 qualified medical facilities. The study uses an electronic data capture tool to collect the de-identified data to create a global multi-center registry. This registry will be used for scientific analysis and publication of pertinent medical trends such as CT utilization, radiation dose, and common cardiovascular findings.
Read the detailed description
The recently developed technique of Cardiac CT Perfusion (CTP) gathers information on both coronary anatomy and myocardial perfusion in a single scan. This diagnostic test can detect the presence of coronary plaque as well as assess the functional significance of a stenosis. To date, it is estimated that 1000 cases of CTP have been performed in the world. While no exceptional adverse events have been reported (nor are expected), the image quality and clinical validation in a multi-center multi-vendor setting has been a marked issue for many experts in this nascent field. This issue has hampered the clinical utility of this test and raises concerns about its widespread utilization leading to unnecessary costs and exposure to radiation.
Historically, the rapid explosion in the use of a related procedure, Cardiac CT Angiography (CCTA) started in 2004 and was marked by large-scale variation in radiation dose, quality issues, inappropriate use, and interpretation proficiency. Critics of the rapid growth of CCTA defamed the procedure for imaging abuse charges and noted unchecked and irresponsible use radiation.
The purpose of RECRUIT is to prevent this clinical inefficiency from occurring again. The main goal of RECRUIT is to determine the best practices for optimal acquisition and interpretation of the CTP images, in an effort to optimize standards before the inevitable rapid adoption of this potentially revolutionary technology. RECRUIT will aim to maximize the clinical effectiveness and minimize the clinical risks associated with CTP before the protocol becomes integrated into the standard-of-care and harmonization of the best practices is nearly impossible.
RECRUIT will enable select clinics that are currently performing CCTA to perform CTP by training them on the latest acquisition techniques as provided by the field leaders in CTP. In addition to providing the acquisition protocol, our researchers will provide the clinical team with a sophisticated EDC tool that effectively monitors numerous factors that could influence the quality of the images. Finally, RECRUIT will collect de-identified images from the sites for analysis in our core lab. Analysis of the images will be correlated with acquisition techniques and patient factors (i.e. BMI). This information fed back to the clinical team that performed the procedure in an effort to improve their proficiency. This process will proceed in an iterative manner, with all endpoints being tracked for reporting in peer-reviewed literature.
- Conditions
- Coronary Artery Disease
- Keywords
- Cardiac CT, heart disease
- Medical subject headings
- Coronary Artery Disease, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CCTA patients | Prior stress SPECT with intermediate to high likelihood to be referred to the cardiac catheterization laboratory for an invasive coronary angiogram or patients presenting with chest pain and clinical indication of Coronary CT Angiography and an initial calcium score above 300 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Practices for CTP
Collect DICOM cases and determine the best practices for CTP, including radiation dose, image quality and patient comfort
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2011 (estimated)
- Study startMay 2011
- Primary completionAug 2012
- Study completionAug 2012
Why it stopped: No funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- MDDX LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Inc
- Responsible party
- Sponsor
- Investigators
- Ricardo Cury, MD, Principal investigator, Miami BaptistJames Min, MD, Study chair, Cedars Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01346605
- Sponsor's protocol ID
- RECRUIT Study
- Acronym
- RECRUIT
- Status last verified
- Dec 2012
- First submitted
- 30 Apr 2011
- Last updated
- 11 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry for CARDIAC PERFUSION CT
- ClinicalTrials.gov ID
- NCT01346605
- Acronym / sponsor ID
- RECRUIT / RECRUIT Study
- Conditions
- Coronary Artery Disease
- Keywords
- Cardiac CT, heart disease
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- MDDX LLCIndustry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Inc
- Study start
- May 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 3 May 2011 (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.
This protocol describes a study whose goal is to collect de-identified Cardiac CT Perfusion (CTP) acquisition parameters and clinical findings from approximately 20 qualified medical facilities. The study uses an electronic data capture tool to collect the de-identified data to create a global multi-center registry. This registry will be used for scientific analysis and publication of pertinent medical trends such as CT utilization, radiation dose, and common cardiovascular findings.
Detailed description
The recently developed technique of Cardiac CT Perfusion (CTP) gathers information on both coronary anatomy and myocardial perfusion in a single scan. This diagnostic test can detect the presence of coronary plaque as well as assess the functional significance of a stenosis. To date, it is estimated that 1000 cases of CTP have been performed in the world. While no exceptional adverse events have been reported (nor are expected), the image quality and clinical validation in a multi-center multi-vendor setting has been a marked issue for many experts in this nascent field. This issue has hampered the clinical utility of this test and raises concerns about its widespread utilization leading to unnecessary costs and exposure to radiation.
Historically, the rapid explosion in the use of a related procedure, Cardiac CT Angiography (CCTA) started in 2004 and was marked by large-scale variation in radiation dose, quality issues, inappropriate use, and interpretation proficiency. Critics of the rapid growth of CCTA defamed the procedure for imaging abuse charges and noted unchecked and irresponsible use radiation.
The purpose of RECRUIT is to prevent this clinical inefficiency from occurring again. The main goal of RECRUIT is to determine the best practices for optimal acquisition and interpretation of the CTP images, in an effort to optimize standards before the inevitable rapid adoption of this potentially revolutionary technology. RECRUIT will aim to maximize the clinical effectiveness and minimize the clinical risks associated with CTP before the protocol becomes integrated into the standard-of-care and harmonization of the best practices is nearly impossible.
RECRUIT will enable select clinics that are currently performing CCTA to perform CTP by training them on the latest acquisition techniques as provided by the field leaders in CTP. In addition to providing the acquisition protocol, our researchers will provide the clinical team with a sophisticated EDC tool that effectively monitors numerous factors that could influence the quality of the images. Finally, RECRUIT will collect de-identified images from the sites for analysis in our core lab. Analysis of the images will be correlated with acquisition techniques and patient factors (i.e. BMI). This information fed back to the clinical team that performed the procedure in an effort to improve their proficiency. This process will proceed in an iterative manner, with all endpoints being tracked for reporting in peer-reviewed literature.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CCTA patients | – | –Prior stress SPECT with intermediate to high likelihood to be referred to the cardiac catheterization laboratory for an invasive coronary angiogram or patients presenting with chest pain and clinical indication of Coronary CT Angiography and an initial calcium score above 300 |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Prior stress SPECT with intermediate to high likelihood to be referred to the cardiac catheterization laboratory for an invasive coronary angiogram or patients presenting with chest pain and clinical indication of Coronary CT Angiography and an initial calcium score above 300
Key inclusion criteria (4 listed)
- Moderate-high likelihood of coronary artery disease with a prior stress SPECTMPI exam likely to be referred to the cardiac catheterization laboratory for invasive angiogram or patients presenting with clinical indication of Coronary -CT Angiography and an initial calcium score above 300
- Stable angina or anginal equivalent as the chief symptom.
- Age > 34 years old
- Able to comprehend and sign the consent form.
Key exclusion criteria (13 listed)
- BMI<41
- Acute coronary syndromes (unstable angina, non-ST elevation myocardial infarction, ST elevation myocardial infarction)
- Unstable clinical conditions (i.e. hemodynamic instability, arrhythmias)
- Premenopausal women who have menstruated in the last year
- Glomerular Filtration Rate (GFR) < 60 ml/min/BSA as an indicator of renal insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Best Practices for CTP
Time frame: 2 years
Collect DICOM cases and determine the best practices for CTP, including radiation dose, image quality and patient comfort
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2012.
Related trials for Coronary Artery Disease
Not yet recruiting
GOT VOICE Feasibility With In-Person Group Singing
Elderly, Coronary Arterial Disease (CAD)
RecruitingObservational study
Real-life Registry in Patients With Coronary Artery Disease Treated With the SELUTION Sirolimus-eluting Balloon. Selution Iberia Registry
Cardiovascular Diseases
Recruiting
Lifewise Preventive Video Education in Primary Care
Prevention Harmful Effects, Health Maintenance
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
Active, not recruiting
Comparison of Vessel-FFR Versus FFR in Intermediate Coronary Stenoses
Coronary Artery Disease, Coronary Artery Stenoses
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.
Ricardo Cury, MD principal investigator
Miami Baptist
James Min, MD study chair
Cedars Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by MDDX LLC at 1 site in United States.
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 4 inclusion and 13 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: withdrawn, as of the sponsor's last update on 11 Dec 2012. 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 United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Best Practices for CTP (time frame: 2 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 11 Dec 2012.