Coronary Artery DiseaseNCT01321970
Validation/Evaluation of Multimodal Imaging Combining 3D Ultrasound and Stress Myocardial Scintigraphy in the Diagnosis of Coronary Artery Disease
A study testing Stress ultrasound, Scintigraphy and Coronary angiography in people with Coronary Artery Disease and Coronary Disease, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
Our primary goal is to validate a new diagnostic tool for functional coronary artery stenosis that uses multimodal imaging (combining stress echocardiography and stress scintigraphy) in patients with known coronary chest pain. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease, Coronary Disease
- What is being tested?
- Stress ultrasound, Scintigraphy and Coronary angiography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2013to Dec 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- The patient has a documented coronaropathy
- The patient needs a new coronarography following symptoms indicating a change in his/her coronary disease state
Who cannot join
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
- The patient is pregnant
Show all 17Show fewer
- The patient is breastfeeding
- Patients with arrhythmias, left bundle branch block on the electrocardiogram which would complicate the interpretation of examinations
- Unstable, acute coronary syndromes unstable needing emergency coronary angiography
- Patient with contraindication for conducting a stress test:
- poorly controlled hypertension
- pre-existing severe arrhythmia
- aortic stenosis
- and obstructive hypertrophic cardiomyopathy
- Patient has contraindication for atropine
- History of prostate adenoma
- Glaucoma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation and Evaluation of Multimodal Imaging Combining Three-dimensional Ultrasound and Stress Myocardial Scintigraphy in the Diagnosis of Coronary Artery Disease
Our primary goal is to validate a new diagnostic tool for functional coronary artery stenosis that uses multimodal imaging (combining stress echocardiography and stress scintigraphy) in patients with known coronary chest pain.
- Conditions
- Coronary Artery Disease, Coronary Disease
- Being tested
- Stress ultrasound, Scintigraphy, Coronary angiography
- Medical subject headings
- Coronary Artery Disease, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress ultrasoundProcedure or surgery
Qualitative interpretation of the left ventricular wall motion abnormalities is performed in real time in the resting phase and during pharmacological stress. The translation of quantitative data is then performed for each of the 17 segments on a bulls-eye pattern identical to that of scintigraphy.
ScintigraphyProcedure or surgery
Image acquisition is synchronized to the electrocardiogram. The tomographic sections are represented in the 3 directions of space, the analysis is also done on the classical representation in 17 segments. (Typically used in ultrasound perfusion scintigraphy or PET).
Coronary angiographyProcedure or surgery
Performed in interventional cardiology setting using a guide introduced through the radial or femoral artery. The injection of iodine allows opacification of coronary arteries and their visualization by fluoroscopy. The qualitative interpretation of the data is translated in terms of percentage of stenosis of the coronary artery. It is thus considered that the stenosis is significant at over 70% obstruction of the lumenal diameter. This interpretation is made for each of the three main coronary arteries and their tributaries:
- Right coronary (proximal, middle and distal) and collateral (inter ventricular posterior ventricular posterior retro)
- Inter ventricular anterior (proximal, middle and distal) and its tributaries (diagonal and septal)
- Circumflex (proximal, middle and distal) and collateral (first and second marginal)
| Study group | Role | What they receive |
|---|---|---|
| Severe coronary artery disease | Other | Patients in this group have coronary artery disease with a stenosis of >70%. Receives: Procedure: Stress ultrasound; Procedure: Scintigraphy; Procedure: Coronary angiography |
| Coronary artery disease | Other | Patients in this group have coronary artery disease with stenosis < 70%. Receives: Procedure: Stress ultrasound; Procedure: Scintigraphy; Procedure: Coronary angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference between AUCs for multimodal imaging and scintigraphy
Measured: 4 days
Secondary outcomes (1)
The difference between AUCs for multimodal imaging and stress ultrasound
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2011 (estimated)
- Study startJun 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Why it stopped: Impossible to start to the study.
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.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Madeleine Rubini, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01321970
- Sponsor's protocol ID
- AOI/2009/VB-01
- Status last verified
- Mar 2015
- First submitted
- 23 Mar 2011
- Last updated
- 19 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation and Evaluation of Multimodal Imaging Combining Three-dimensional Ultrasound and Stress Myocardial Scintigraphy in the Diagnosis of Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT01321970
- Acronym / sponsor ID
- AOI/2009/VB-01
- Conditions
- Coronary Artery Disease, Coronary Disease
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Impossible to start to the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Jun 2013 (actual)
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 24 Mar 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.
Our primary goal is to validate a new diagnostic tool for functional coronary artery stenosis that uses multimodal imaging (combining stress echocardiography and stress scintigraphy) in patients with known coronary chest pain.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Severe coronary artery disease | Other | Procedure: Stress ultrasound, Procedure: Scintigraphy, Procedure: Coronary angiographyPatients in this group have coronary artery disease with a stenosis of >70%. |
| Coronary artery disease | Other | Procedure: Stress ultrasound, Procedure: Scintigraphy, Procedure: Coronary angiographyPatients in this group have coronary artery disease with stenosis < 70%. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- The patient has a documented coronaropathy
- The patient needs a new coronarography following symptoms indicating a change in his/her coronary disease state
Key exclusion criteria (17 listed)
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
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 |
|---|---|---|
| Stress ultrasoundQualitative interpretation of the left ventricular wall motion abnormalities is performed in real time in the resting phase and during pharmacological stress. The translation of quantitative data is then performed for each of the 17 segments on a bulls-eye pattern identical to that of scintigraphy. | Procedure or surgery | Coronary artery disease, Severe coronary artery disease |
| ScintigraphyImage acquisition is synchronized to the electrocardiogram. The tomographic sections are represented in the 3 directions of space, the analysis is also done on the classical representation in 17 segments. (Typically used in ultrasound perfusion scintigraphy or PET). | Procedure or surgery | Coronary artery disease, Severe coronary artery disease |
| Coronary angiographyPerformed in interventional cardiology setting using a guide introduced through the radial or femoral artery. The injection of iodine allows opacification of coronary arteries and their visualization by fluoroscopy. The qualitative interpretation of the data is translated in terms of percentage of stenosis of the coronary artery. It is thus considered that the stenosis is significant at over 70% obstruction of the lumenal diameter. This interpretation is made for each of the three main coronary arteries and their tributaries: * Right coronary (proximal, middle and distal) and collateral (inter ventricular posterior ventricular posterior retro) * Inter ventricular anterior (proximal, middle and distal) and its tributaries (diagonal and septal) * Circumflex (proximal, middle and distal) and collateral (first and second marginal) | Procedure or surgery | Coronary artery disease, Severe coronary artery disease |
Primary outcome
The difference between AUCs for multimodal imaging and scintigraphy
Time frame: 4 days
1 secondary outcome
The difference between AUCs for multimodal imaging and stress ultrasound
Time frame: 4 days
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 19 Jun 2017.
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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.
Madeleine Rubini, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress ultrasound, Scintigraphy and Coronary angiography in people with Coronary Artery Disease and Coronary Disease, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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 17 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 19 Jun 2017. 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 France. 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?
The difference between AUCs for multimodal imaging and scintigraphy (time frame: 4 days). 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 19 Jun 2017.