Coronary Artery DiseaseFlow-HeartNCT02844686
Myocardial Flow Reserve and 99mTc-DTPA Cardiac Dynamic SPECT
A study testing Cardiac SPECT in people with Coronary Artery Disease, run by University Hospital, Caen.
Trial summary
New CZT-based SPECT cameras are potentially capable of dynamic 3-D acquisition. Preliminary results suggested that dynamic acquisitions could allow the assessment of myocardial flow reserve using 99mTc-labelled perfusion tracers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Cardiac SPECT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Aug 2018
- 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
- Age over 18 years
- Patient clinically stable with known or suspected coronary disease
- Patient referred to Caen University Hospital for a myocardial perfusion SPECT
- Patient who accept to undergo subsequent additional cardiac dynamic SPECT using 99mTc-DTPA at rest and during pharmacological stress
- Informed consent dated and signed
- Affiliation to a social security system
Who cannot join
- Contraindication to dipyridamole (asthma, chronic obstructive pulmonary disease , pulmonary hypertension)
- History of poor tolerance of dipyridamole injection
- Cardiac arrhythmia (atrial fibrillation or frequent premature ventricular complex)
- Left bundle branch block, cardiac pacemaker, or implantable automatic defibrillator
- Recent history of myocardial infarction or unstable angina
- Pregnancy or lactating women
Show all 9Show fewer
- Known obstructive renal or urinary disease
- Age under 18 years or guardianship
- Patient with an acute coronary syndrome or a coronary revascularization occurring between the conventional perfusion SPECT and the subsequent 99mTc-DTPA dynamic SPECT
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Feasibility of Dynamic Cardiac SPECT With 99mTc-diethylenetriaminepenta-acetate (DTPA) for the Assessment of Myocardial Flow Reserve Using a Cadmium-Zinc-Telluride (CZT) Camera
New CZT-based SPECT cameras are potentially capable of dynamic 3-D acquisition. Preliminary results suggested that dynamic acquisitions could allow the assessment of myocardial flow reserve using 99mTc-labelled perfusion tracers. The Flow-Heart study will assess the feasibility of myocardial flow reserve measurement by means of 99mTc-DTPA dynamic cardiac SPECT in 20 patients.
- Conditions
- Coronary Artery Disease
- Being tested
- Cardiac SPECT
- Keywords
- Myocardial perfusion imaging, Single-Photon Emission Computer-Assisted Tomography
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac SPECTOther
3-D dynamic acquisition of cardiac SPECT at rest and after pharmacological stress
| Study group | Role | What they receive |
|---|---|---|
| Cardiac Dynamic SPECT | Experimental | Not described Receives: Other: Cardiac SPECT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of myocardial flow reserve assessment by dynamic cardiac SPECT using a CZT camera and 99mTc-DTPA
Measured: Within one month after a conventional myocardial perfusion SPECT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2018 (estimated)
- Study completionAug 2018 (estimated)
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 University Hospital, CaenThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alain Manrique, MD, PhD, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02844686
- Sponsor's protocol ID
- 16-004
- Other IDs
- 2016-000119-34, 2016
- Acronym
- Flow-Heart
- Status last verified
- Jul 2016
- First submitted
- 21 Jul 2016
- Last updated
- 26 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Dynamic Cardiac SPECT With 99mTc-diethylenetriaminepenta-acetate (DTPA) for the Assessment of Myocardial Flow Reserve Using a Cadmium-Zinc-Telluride (CZT) Camera
- ClinicalTrials.gov ID
- NCT02844686
- Acronym / sponsor ID
- Flow-Heart / 16-004
- Conditions
- Coronary Artery Disease
- Keywords
- Myocardial perfusion imaging, Single-Photon Emission Computer-Assisted Tomography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 26 Jul 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.
New CZT-based SPECT cameras are potentially capable of dynamic 3-D acquisition. Preliminary results suggested that dynamic acquisitions could allow the assessment of myocardial flow reserve using 99mTc-labelled perfusion tracers. The Flow-Heart study will assess the feasibility of myocardial flow reserve measurement by means of 99mTc-DTPA dynamic cardiac SPECT in 20 patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac Dynamic SPECT | Experimental | Other: Cardiac SPECT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age over 18 years
- Patient clinically stable with known or suspected coronary disease
- Patient referred to Caen University Hospital for a myocardial perfusion SPECT
- Patient who accept to undergo subsequent additional cardiac dynamic SPECT using 99mTc-DTPA at rest and during pharmacological stress
- Informed consent dated and signed
Key exclusion criteria (9 listed)
- Contraindication to dipyridamole (asthma, chronic obstructive pulmonary disease , pulmonary hypertension)
- History of poor tolerance of dipyridamole injection
- Cardiac arrhythmia (atrial fibrillation or frequent premature ventricular complex)
- Left bundle branch block, cardiac pacemaker, or implantable automatic defibrillator
- Recent history of myocardial infarction or unstable angina
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 |
|---|---|---|
| Cardiac SPECT3-D dynamic acquisition of cardiac SPECT at rest and after pharmacological stress | Other | Cardiac Dynamic SPECT |
Primary outcome
Feasibility of myocardial flow reserve assessment by dynamic cardiac SPECT using a CZT camera and 99mTc-DTPA
Time frame: Within one month after a conventional myocardial perfusion SPECT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
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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.
Alain Manrique, MD, PhD principal investigator
University Hospital, Caen
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac SPECT in people with Coronary Artery Disease, run by University Hospital, Caen.
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 9 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 26 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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 Alain Manrique, MD, PhD ((+33) 231 470 287, manrique@cyceron.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of myocardial flow reserve assessment by dynamic cardiac SPECT using a CZT camera and 99mTc-DTPA (time frame: Within one month after a conventional myocardial perfusion 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 26 Jul 2016.