Attenuation ArtifactD-SPECT BIKERNCT02872545
Influence of Patient Position on Attenuation Artifacts Observed in D-SPECT Camera Myocardial Tomoscintigraphy
A study testing Rest tomoscintigraphy in forward tilted, Rest tomoscintigraphy in semi sitting position and Rest tomoscintigraphy in dorsal decubitus position in people with Attenuation Artifact and Myocardial Tomoscintigraphy, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The purpose is to compare percentages of myocardial segments showing attenuation in patients in forward tilted position (biker position) or 2 conventional positions (dorsal decubitus or semi sitting) at acquisition with D-SPECT camera in myocardial tomoscintigraphy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Attenuation Artifact, Myocardial Tomoscintigraphy, Patient Position
- What is being tested?
- Rest tomoscintigraphy in forward tilted, Rest tomoscintigraphy in semi sitting position and Rest tomoscintigraphy in dorsal decubitus position
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2016to Jun 2017
- 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
- Affiliation to social security
- Signed informed consent
- Previous clinical examination authorizing patient to undergo tomoscintigraphy
- Patient with abnormal results of stress tomoscintigraphy and needing a rest tomoscintigraphy
- Patient with sinus and regular cardiac rhythm
- Patient with stable clinical status (without signs of unstable cardiac or coronary failure, without uncontrolled hypertension under treatment)
Who cannot join
- Women of childbearing potential without effective contraception
- Evolutive pregnancy
- Breastfeeding patient
- Contraindication to tomoscintigraphy
- Patient with history of hypersensibility to tomography radiotracer STAMICIS® or one of components
- Patient in life-and-death emergency
Show all 10Show fewer
- Patient with history of disorders possibly interfering with contractility
- Patient with normal results of stress tomoscintigraphy
- Person under legal protection or incapable to consent
- Person deprived of liberty by judicial or administrative decision
Trial locations and contacts
1 site in 1 country.
Mathieu PERRIN, Dr contact
France1 site, 1 recruiting
- Recruiting
Service de Médecine Nucléaire - CHRU de Nancy-Brabois
Vandœuvre-lès-Nancy
About this study
The purpose is to compare percentages of myocardial segments showing attenuation in patients in forward tilted position (biker position) or 2 conventional positions (dorsal decubitus or semi sitting) at acquisition with D-SPECT camera in myocardial tomoscintigraphy.
The hypothesis is that the percentage of myocardial segments with attenuation is significantly lower when acquisitions are made in forward tilted position (biker position).
The secondary purpose is to restrict this analysis to 3 cardiac regions most subject to attenuation artifacts (anterior, apical and inferobasal regions).
Read the detailed description
Myocardial perfusion tomoscintigraphy is a very used technique for diagnosis and characterization of abnormalities of stress and rest myocardial perfusion (ischemia, infarction).
A common problem is attenuation artifacts that are due to tissue interposition attenuating radiation from some cardiac regions. These artifacts originate activity decreasing and thus perfusion abnormalities potentially in all walls of left ventricle, especially the inferior wall in men (attenuation by sub-diaphragmatic organs) and the anterior wall in women (attenuation by mammary glands). These artifacts are observed in rest and stress acquisitions and can lead to a wrong diagnosis of infarction.
Attenuation artifacts can be identified with analysis of contraction kinetics with "gated-SPECT" (normal kinetics and thus discordant with aspect of infarction). With D-SPECT camera some artifacts can be prevented with a 30-35° forward tilted position of acquisition. This position, also called biker position, can take cardiac area away from sub-diaphragmatic structures. It can also reduce the distance between heart and detection surface of camera and limit respiratory movements of thoracic wall.
In this study, patients with abnormal results at stress myocardial perfusion tomoscintigraphy will undergo a rest tomoscintigraphy. Acquisition will be done in forward tilted position and in one of 2 other positions: dorsal decubitus or semi sitting.
- Being tested
- Rest tomoscintigraphy in forward tilted, Rest tomoscintigraphy in semi sitting position, Rest tomoscintigraphy in dorsal decubitus position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rest tomoscintigraphy in forward tiltedProcedure or surgery
Rest tomoscintigraphy in forward tilted position
Rest tomoscintigraphy in semi sitting positionProcedure or surgery
Rest tomoscintigraphy in forward tilted position, followed by a second rest tomoscintigraphy in semi sitting position, after max 30 min
Rest tomoscintigraphy in dorsal decubitus positionProcedure or surgery
Rest tomoscintigraphy in forward tilted position, followed by a second rest tomoscintigraphy in semi sitting position, after max 30 min
| Study group | Role | What they receive |
|---|---|---|
| forward tilted | Experimental | Patients with abnormal results at stress myocardial perfusion tomoscintigraphy will undergo a rest tomoscintigraphy. Acquisition will be done in forward tilted position Receives: Procedure: Rest tomoscintigraphy in forward tilted; Procedure: Rest tomoscintigraphy in semi sitting position; Procedure: Rest tomoscintigraphy in dorsal decubitus position |
| semi sitting | Other | Patients with abnormal results at stress myocardial perfusion tomoscintigraphy will undergo a rest tomoscintigraphy. Acquisition will be done in semi sitting Receives: Procedure: Rest tomoscintigraphy in forward tilted; Procedure: Rest tomoscintigraphy in semi sitting position |
| dorsal decubitus | Other | Patients with abnormal results at stress myocardial perfusion tomoscintigraphy will undergo a rest tomoscintigraphy. Acquisition will be done in dorsal decubitus Receives: Procedure: Rest tomoscintigraphy in forward tilted; Procedure: Rest tomoscintigraphy in dorsal decubitus position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of myocardial segments classified with attenuation artifact
With infarction aspect but normal contraction kinetics in Gated-SPECT analysis.
Left ventricle is divided in 17 segments according to American Heart Association.
Measured: day 0
Secondary outcomes (3)
Percentage of myocardial segments classified with attenuation artifact in anterior region
Measured: day 0
Percentage of myocardial segments classified with attenuation artifact in apical region
Measured: day 0
Percentage of myocardial segments classified with attenuation artifact in inferobasal region
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attenuation ArtifactStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mathieu PERRIN, Dr, Principal investigator, Service de Médecine Nucléaire - CHRU de Nancy-Brabois - Vandoeuvre Lès Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02872545
- Sponsor's protocol ID
- 2016-A00378-43
- Acronym
- D-SPECT BIKER
- Status last verified
- Aug 2016
- First submitted
- 16 Aug 2016
- Last updated
- 19 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Patient Position on Attenuation Artifacts Observed in D-SPECT Camera Myocardial Tomoscintigraphy
- ClinicalTrials.gov ID
- NCT02872545
- Acronym / sponsor ID
- D-SPECT BIKER / 2016-A00378-43
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 19 Aug 2016 (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 purpose is to compare percentages of myocardial segments showing attenuation in patients in forward tilted position (biker position) or 2 conventional positions (dorsal decubitus or semi sitting) at acquisition with D-SPECT camera in myocardial tomoscintigraphy.
The hypothesis is that the percentage of myocardial segments with attenuation is significantly lower when acquisitions are made in forward tilted position (biker position).
The secondary purpose is to restrict this analysis to 3 cardiac regions most subject to attenuation artifacts (anterior, apical and inferobasal regions).
Detailed description
Myocardial perfusion tomoscintigraphy is a very used technique for diagnosis and characterization of abnormalities of stress and rest myocardial perfusion (ischemia, infarction).
A common problem is attenuation artifacts that are due to tissue interposition attenuating radiation from some cardiac regions. These artifacts originate activity decreasing and thus perfusion abnormalities potentially in all walls of left ventricle, especially the inferior wall in men (attenuation by sub-diaphragmatic organs) and the anterior wall in women (attenuation by mammary glands). These artifacts are observed in rest and stress acquisitions and can lead to a wrong diagnosis of infarction.
Attenuation artifacts can be identified with analysis of contraction kinetics with "gated-SPECT" (normal kinetics and thus discordant with aspect of infarction). With D-SPECT camera some artifacts can be prevented with a 30-35° forward tilted position of acquisition. This position, also called biker position, can take cardiac area away from sub-diaphragmatic structures. It can also reduce the distance between heart and detection surface of camera and limit respiratory movements of thoracic wall.
In this study, patients with abnormal results at stress myocardial perfusion tomoscintigraphy will undergo a rest tomoscintigraphy. Acquisition will be done in forward tilted position and in one of 2 other positions: dorsal decubitus or semi sitting.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| forward tilted | Experimental | Procedure: Rest tomoscintigraphy in forward tilted, Procedure: Rest tomoscintigraphy in semi sitting position, Procedure: Rest tomoscintigraphy in dorsal decubitus positionPatients with abnormal results at stress myocardial perfusion tomoscintigraphy will undergo a rest tomoscintigraphy. Acquisition will be done in forward tilted position |
| semi sitting | Other | Procedure: Rest tomoscintigraphy in forward tilted, Procedure: Rest tomoscintigraphy in semi sitting positionPatients with abnormal results at stress myocardial perfusion tomoscintigraphy will undergo a rest tomoscintigraphy. Acquisition will be done in semi sitting |
| dorsal decubitus | Other | Procedure: Rest tomoscintigraphy in forward tilted, Procedure: Rest tomoscintigraphy in dorsal decubitus positionPatients with abnormal results at stress myocardial perfusion tomoscintigraphy will undergo a rest tomoscintigraphy. Acquisition will be done in dorsal decubitus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Affiliation to social security
- Signed informed consent
- Previous clinical examination authorizing patient to undergo tomoscintigraphy
- Patient with abnormal results of stress tomoscintigraphy and needing a rest tomoscintigraphy
- Patient with sinus and regular cardiac rhythm
Key exclusion criteria (10 listed)
- Women of childbearing potential without effective contraception
- Evolutive pregnancy
- Breastfeeding patient
- Contraindication to tomoscintigraphy
- Patient with history of hypersensibility to tomography radiotracer STAMICIS® or one of components
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 |
|---|---|---|
| Rest tomoscintigraphy in forward tiltedRest tomoscintigraphy in forward tilted position | Procedure or surgery | dorsal decubitus, forward tilted, semi sitting |
| Rest tomoscintigraphy in semi sitting positionRest tomoscintigraphy in forward tilted position, followed by a second rest tomoscintigraphy in semi sitting position, after max 30 min | Procedure or surgery | forward tilted, semi sitting |
| Rest tomoscintigraphy in dorsal decubitus positionRest tomoscintigraphy in forward tilted position, followed by a second rest tomoscintigraphy in semi sitting position, after max 30 min | Procedure or surgery | dorsal decubitus, forward tilted |
Primary outcome
Percentage of myocardial segments classified with attenuation artifact
Time frame: day 0
With infarction aspect but normal contraction kinetics in Gated-SPECT analysis. Left ventricle is divided in 17 segments according to American Heart Association.
3 secondary outcomes
Percentage of myocardial segments classified with attenuation artifact in anterior region
Time frame: day 0
Percentage of myocardial segments classified with attenuation artifact in apical region
Time frame: day 0
Percentage of myocardial segments classified with attenuation artifact in inferobasal region
Time frame: day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2016.
- Individual participant dataSharing planned: No
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.
Mathieu PERRIN, Dr contact
Mathieu PERRIN, Dr principal investigator
Service de Médecine Nucléaire - CHRU de Nancy-Brabois - Vandoeuvre Lès Nancy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rest tomoscintigraphy in forward tilted, Rest tomoscintigraphy in semi sitting position and Rest tomoscintigraphy in dorsal decubitus position in people with Attenuation Artifact and Myocardial Tomoscintigraphy, run by Central Hospital, Nancy, France 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 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: status not confirmed, as of the sponsor's last update on 19 Aug 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mathieu PERRIN, Dr (matperrin@yahoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of myocardial segments classified with attenuation artifact (time frame: day 0). 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 Aug 2016.