Coronary Heart DiseaseERCADNCT03326167
Determination of Coronary Flow Reserve by Dynamic Myocardial Perfusion Scintigraphy
An observational study of Coronary Heart Disease, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Because of its availability, non-invasiveness, and high diagnostic performance, myocardial perfusion tomoscintigraphy has become a standard tool for the detection, characterization and monitoring of coronary artery disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- Myocardial Perfusion Imaging by Single Photon Emission Computed Tomography (MPI SPECT)
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 15 Nov 2017to 13 Mar 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study is conducted in adults with suspected coronary artery disease or coronary heart disease and referred for functional evaluation by perfusion scintigraphy with dynamic acquisition before coronary angiography.
Who may be able to join
- Patients sent to the Nuclear Medicine Department as part of a functional evaluation by dynamic acquisition tomoscintigraphy and who will benefit from coronary angiography in the Louis Pradel Hospital hemodynamics department, depending on the results and the clinical context , outside of an emergency context.
- Patients who received the information and did not object to participate in the study
Who cannot join
- Patient with a contraindication to pharmacological stress by dipyridamole or regadenoson (acute coronary syndrome, acute pulmonary embolism, hypertension) severe pulmonary artery disease, acute aortic dissection, symptomatic aortic stenosis, hemodynamic instability, acute myocarditis, pericarditis or endocarditis, severe chronic obstructive pulmonary disease, uncompacted type III atrioventricular block, systolic pressure <90 mmHg, Recent ischemic stroke, hypersensitivity or allergy to active ingredients or excipients)
- Patients under 18 years of age
- Patients with atrial fibrillation complete arrhythmia (ACFA)
- Patients with a history of coronary bypass grafting.
- Patients whose clinical condition requires rapid management not allowing to wait for the completion of the exams
- Pregnancy and breast feeding
- Deprivation of civil rights (guardianship, guardianship, safeguard of justice)
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Médecine Nucléaire - Hôpital Louis Pradel - Hospices Civils de Lyon
Bron, 69677
About this study
Because of its availability, non-invasiveness, and high diagnostic performance, myocardial perfusion tomoscintigraphy has become a standard tool for the detection, characterization and monitoring of coronary artery disease. Standard analysis, based on the reversibility of regional myocardial hypoperfusion between stress (physiological or pharmacological) and rest, has good sensitivity and negative predictive value in the search for myocardial ischemia. However, two major obstacles persist. First, because of the relative nature of the normalization of cardiac activity, this approach may underestimate the extent of the damage, especially when the territory with the most activity is itself pathological. Thus myocardial perfusion scintigraphy can only detect 40 to 50% of tri-truncal patients. To overcome these disadvantages, several indexes have been proposed to improve the diagnostic performance of perfusion scintigraphy in multi-truncal patients based in particular on kinetic analysis. Secondly, the review does not provide any guarantee as to the quality and reproducibility of use of the coronal reserve during stress, in particular during submaximal stress tests and pharmacological stress, the latter being easily antagonized by xanthine derivatives contained in tea and coffee in particular (abstinence of at least 12 to 24 hours being recommended). In recent years and thanks to the advent of CZT semiconductor cameras dedicated to cardiology - to perform a dynamic tomographic acquisition - a study of the coronal reserve is feasible by perfusion tomoscintigraphy in current practice. This study of the coronary reserve mainly consists of a computer post-processing of the myocardial perfusion scintigraphy data and does not therefore require any additional irradiation (the only difference with respect to the old protocols is the start of the images at the time of publication. injection of the radiotracer). However, the diagnostic benefit gained from the coronary reserve study compared to conventional stress / rest perfusion scintigraphy has not been clearly studied, particularly in the multi-truncal patients.
- Conditions
- Coronary Heart Disease
- Being tested
- Myocardial Perfusion Imaging by Single Photon Emission Computed Tomography (MPI SPECT)
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myocardial Perfusion Imaging by Single Photon Emission Computed Tomography (MPI SPECT)Other
Evaluation of the improvement of the sensitivity, in tri-truncular patients, provided by the estimation of the coronal reserve by territory, during the realization of a myocardial perfusion tomoscintigraphy on CZT camera dedicated to cardiology (Discovery NM 530 ).
| Study group | Role | What they receive |
|---|---|---|
| Patients with or suspected coronary heart disease | Not described Receives: Other: Myocardial Perfusion Imaging by Single Photon Emission Computed Tomography (MPI SPECT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of significant stenosis in each of the three coronary areas
The gold standard will be provided by coronarography with Fractional Flow Reserve measurement during the angiographic procedure if necessary. Coronary stenosis with Fractional Flow Reserve <0.8 will be retained as positive
Measured: two weeks after MPI SPECT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start15 Nov 2017
- Primary completion13 Mar 2019
- Study completion13 Mar 2019
Why it stopped: recruitment difficulty
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.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03326167
- Sponsor's protocol ID
- 69HCL17_0259
- Acronym
- ERCAD
- Status last verified
- Apr 2023
- First submitted
- 26 Oct 2017
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Coronary Flow Reserve by Dynamic Myocardial Perfusion Scintigraphy
- ClinicalTrials.gov ID
- NCT03326167
- Acronym / sponsor ID
- ERCAD / 69HCL17_0259
- Conditions
- Coronary Heart Disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: recruitment difficulty
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- 13 Mar 2019 (actual)
- Study completion
- 13 Mar 2019 (actual)
- First posted
- 31 Oct 2017 (actual)
- 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.
Because of its availability, non-invasiveness, and high diagnostic performance, myocardial perfusion tomoscintigraphy has become a standard tool for the detection, characterization and monitoring of coronary artery disease. Standard analysis, based on the reversibility of regional myocardial hypoperfusion between stress (physiological or pharmacological) and rest, has good sensitivity and negative predictive value in the search for myocardial ischemia. However, two major obstacles persist. First, because of the relative nature of the normalization of cardiac activity, this approach may underestimate the extent of the damage, especially when the territory with the most activity is itself pathological. Thus myocardial perfusion scintigraphy can only detect 40 to 50% of tri-truncal patients. To overcome these disadvantages, several indexes have been proposed to improve the diagnostic performance of perfusion scintigraphy in multi-truncal patients based in particular on kinetic analysis. Secondly, the review does not provide any guarantee as to the quality and reproducibility of use of the coronal reserve during stress, in particular during submaximal stress tests and pharmacological stress, the latter being easily antagonized by xanthine derivatives contained in tea and coffee in particular (abstinence of at least 12 to 24 hours being recommended). In recent years and thanks to the advent of CZT semiconductor cameras dedicated to cardiology - to perform a dynamic tomographic acquisition - a study of the coronal reserve is feasible by perfusion tomoscintigraphy in current practice. This study of the coronary reserve mainly consists of a computer post-processing of the myocardial perfusion scintigraphy data and does not therefore require any additional irradiation (the only difference with respect to the old protocols is the start of the images at the time of publication. injection of the radiotracer). However, the diagnostic benefit gained from the coronary reserve study compared to conventional stress / rest perfusion scintigraphy has not been clearly studied, particularly in the multi-truncal patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with or suspected coronary heart disease | – | Other: Myocardial Perfusion Imaging by Single Photon Emission Computed Tomography (MPI SPECT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study is conducted in adults with suspected coronary artery disease or coronary heart disease and referred for functional evaluation by perfusion scintigraphy with dynamic acquisition before coronary angiography.
Key inclusion criteria (2 listed)
- Patients sent to the Nuclear Medicine Department as part of a functional evaluation by dynamic acquisition tomoscintigraphy and who will benefit from coronary angiography in the Louis Pradel Hospital hemodynamics department, depending on the results and the clinical context , outside of an emergency context.
- Patients who received the information and did not object to participate in the study
Key exclusion criteria (7 listed)
- Patient with a contraindication to pharmacological stress by dipyridamole or regadenoson (acute coronary syndrome, acute pulmonary embolism, hypertension) severe pulmonary artery disease, acute aortic dissection, symptomatic aortic stenosis, hemodynamic instability, acute myocarditis, pericarditis or endocarditis, severe chronic obstructive pulmonary disease, uncompacted type III atrioventricular block, systolic pressure <90 mmHg, Recent ischemic stroke, hypersensitivity or allergy to active ingredients or excipients)
- Patients under 18 years of age
- Patients with atrial fibrillation complete arrhythmia (ACFA)
- Patients with a history of coronary bypass grafting.
- Patients whose clinical condition requires rapid management not allowing to wait for the completion of the exams
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 |
|---|---|---|
| Myocardial Perfusion Imaging by Single Photon Emission Computed Tomography (MPI SPECT)Evaluation of the improvement of the sensitivity, in tri-truncular patients, provided by the estimation of the coronal reserve by territory, during the realization of a myocardial perfusion tomoscintigraphy on CZT camera dedicated to cardiology (Discovery NM 530 ). | Other | Patients with or suspected coronary heart disease |
Primary outcome
Presence of significant stenosis in each of the three coronary areas
Time frame: two weeks after MPI SPECT
The gold standard will be provided by coronarography with Fractional Flow Reserve measurement during the angiographic procedure if necessary. Coronary stenosis with Fractional Flow Reserve <0.8 will be retained as positive
Results and safety
The study was stopped early (reason given: recruitment difficulty). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Heart Disease, run by Hospices Civils de Lyon 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 2 inclusion and 7 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: stopped early, as of the sponsor's last update on 7 Apr 2023. 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 stopped early (reason given: recruitment difficulty). Results are not available in the source record.
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?
Presence of significant stenosis in each of the three coronary areas (time frame: two weeks after MPI SPECT). 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 7 Apr 2023.