Myocardial Perfusion ImagingREDUCENCT03084562
Regadenoson vs Dipyridamole in Use as Pharmacological Stress Agent Before SPECT
An observational study of Myocardial Perfusion Imaging, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Myocardial perfusion scintigraphy is to evaluate coronary perfusion as well as heart muscle function. This examination takes place in two stages, one imaging at rest and one after a cardiac stress caused. This stress can be triggered as a first-line stress test. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Perfusion Imaging
- What is being tested?
- collect examination time, functional and clinical tolerability
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 3 May 2017to 9 Oct 2017
- 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: Patients reffered for an indication of myocardial perfusion scintigraphy in the nuclear medicine unit
Who may be able to join
- Adult ≥ 18 years
- Myocardial scintigraphy by pharmacological stress agent
- Used molecules = Dipyridamole or Regadenoson
- Double isotope protocol
- Patient refusal due to study information
Who cannot join
- Physical stress test by single or mixed effort (associating pharmacological stress)
- Pharmacological agent used = Adenosine
Trial locations and contacts
1 site in 1 country.
France1 site
Lyon civil Hospital - Est Hospital Complexe - Nuclear Medicine Service
Bron, 69677
About this study
Official title: Descriptive Study Comparing Regadenoson Versus Dipyridamole in Use as Pharmacological Stress Agent Before a Myocardial Perfusion Imaging by Single Photon Emission Computed Tomography (SPECT)
Myocardial perfusion scintigraphy is to evaluate coronary perfusion as well as heart muscle function. This examination takes place in two stages, one imaging at rest and one after a cardiac stress caused. This stress can be triggered as a first-line stress test. A pharmacological stress is proposed when stress test is not possible or contraindicated, Several drugs have a marketing authorization in this indication (adenosine, dipyridamole, regadenoson, dobutamine).
Among them, the regadenoson is the most recent molecule. Marketed in France since 2013, it would allow a reduction of undesirable effects compared to other agents, especially adenosine. It is simple and quick to use thanks to a single dose administration. However, its cost is nearly 30 times higher than dipyridamole. In the investigational center, dipyridamole is currently the first-line pharmacological stress agent, whereas regadenoson is reserved for a limited number of doses, the indication of which must be justified (asthmatic patient or with severe COPD). Few studies in the literature specifically compare these two pharmacological agents (examination time, cost, tolerance) and the opinion on the use of regadenoson in the service is limited.
- Conditions
- Myocardial Perfusion Imaging
- Being tested
- collect examination time, functional and clinical tolerability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collect examination time, functional and clinical tolerabilityOther
Examination time : time from patient setup and launch of the pre-test to the end of the patient monitoring Functional tolerability : functional assessed by the patient Clinical tolerability : clinical score by the cardiologist
| Study group | Role | What they receive |
|---|---|---|
| Dipyridamole | stress test impossible or contraindicated (first intention) Receives: Other: collect examination time, functional and clinical tolerability | |
| Regadenoson | stress test and dipyridamole impossible or contraindicated. In particular, patients with severe COPD or asthmatic patient. (second intention) Receives: Other: collect examination time, functional and clinical tolerability |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of the test
Evaluate the time savings from the use of regadenoson versus dipyridamole by comparing the duration of the test.
Measured: 24 hours (Visit 1: During the examen)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2017
- Study start3 May 2017
- Primary completion9 Oct 2017
- Study completion9 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial Perfusion ImagingStudies 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
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian SCHEIBER, Pr, Principal investigator, Lyon civil Hospital - Est Hospital Complexe - Nuclear Medicine Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03084562
- Sponsor's protocol ID
- 69HCL17_0056
- Acronym
- REDUCE
- Status last verified
- Mar 2017
- First submitted
- 8 Mar 2017
- Last updated
- 13 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descriptive Study Comparing Regadenoson Versus Dipyridamole in Use as Pharmacological Stress Agent Before a Myocardial Perfusion Imaging by Single Photon Emission Computed Tomography (SPECT)
- ClinicalTrials.gov ID
- NCT03084562
- Acronym / sponsor ID
- REDUCE / 69HCL17_0056
- Conditions
- Myocardial Perfusion Imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 3 May 2017 (actual)
- Primary completion
- 9 Oct 2017 (actual)
- Study completion
- 9 Oct 2017 (actual)
- First posted
- 21 Mar 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.
Myocardial perfusion scintigraphy is to evaluate coronary perfusion as well as heart muscle function. This examination takes place in two stages, one imaging at rest and one after a cardiac stress caused. This stress can be triggered as a first-line stress test. A pharmacological stress is proposed when stress test is not possible or contraindicated, Several drugs have a marketing authorization in this indication (adenosine, dipyridamole, regadenoson, dobutamine).
Among them, the regadenoson is the most recent molecule. Marketed in France since 2013, it would allow a reduction of undesirable effects compared to other agents, especially adenosine. It is simple and quick to use thanks to a single dose administration. However, its cost is nearly 30 times higher than dipyridamole. In the investigational center, dipyridamole is currently the first-line pharmacological stress agent, whereas regadenoson is reserved for a limited number of doses, the indication of which must be justified (asthmatic patient or with severe COPD). Few studies in the literature specifically compare these two pharmacological agents (examination time, cost, tolerance) and the opinion on the use of regadenoson in the service is limited.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dipyridamole | – | Other: collect examination time, functional and clinical tolerabilitystress test impossible or contraindicated (first intention) |
| Regadenoson | – | Other: collect examination time, functional and clinical tolerabilitystress test and dipyridamole impossible or contraindicated. In particular, patients with severe COPD or asthmatic patient. (second intention) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients reffered for an indication of myocardial perfusion scintigraphy in the nuclear medicine unit
Key inclusion criteria (5 listed)
- Adult ≥ 18 years
- Myocardial scintigraphy by pharmacological stress agent
- Used molecules = Dipyridamole or Regadenoson
- Double isotope protocol
- Patient refusal due to study information
Key exclusion criteria (2 listed)
- Physical stress test by single or mixed effort (associating pharmacological stress)
- Pharmacological agent used = Adenosine
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 |
|---|---|---|
| collect examination time, functional and clinical tolerabilityExamination time : time from patient setup and launch of the pre-test to the end of the patient monitoring Functional tolerability : functional assessed by the patient Clinical tolerability : clinical score by the cardiologist | Other | Dipyridamole, Regadenoson |
Primary outcome
Duration of the test
Time frame: 24 hours (Visit 1: During the examen)
Evaluate the time savings from the use of regadenoson versus dipyridamole by comparing the duration of the test.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2018.
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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.
Christian SCHEIBER, Pr principal investigator
Lyon civil Hospital - Est Hospital Complexe - Nuclear Medicine Service
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 Myocardial Perfusion Imaging, 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 5 inclusion and 2 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: finished, as of the sponsor's last update on 13 Apr 2018. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Duration of the test (time frame: 24 hours (Visit 1: During the examen)). 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 13 Apr 2018.