Coronary Artery DiseaseNCT02136706
Feasibility and Diagnostic Accuracy of Myocardial SPECT Using Early Imaging Protocol
A study testing Myocardial Perfusion imaging with 10 minute waiting period in people with Coronary Artery Disease and Atherosclerosis, run by Medhat Osman MD.
Trial summary
Encouraged by the recent data published ,the investigators think that a waiting time of 10 minutes is feasible while preserving diagnostic accuracy and would like to assess the feasibility and diagnostic efficacy of W10 compared with W30 imaging in a pilot study. Read more about this study
- Who is it for?
- Ages 18 to 88 years
- Conditions the study is for
- Coronary Artery Disease, Atherosclerosis
- What is being tested?
- Myocardial Perfusion imaging with 10 minute waiting period
- 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
- No sites listed yet
- Study dates
- Dec 2015to Apr 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 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women ≥18 and ≤ 89 years of age of any race /ethnicity
- Patient has undergone or is being scheduled for a clinically indicated CardiacCath with or without angioplasty
- Patient may have suffered myocardial infarction more than 3 days before T99m-MPI
- Patient may have undergone percutaneous transluminal coronary angioplasty (PTCA) or coronary stent placement more than 3 days prior to T99m-Myocardial Perfusion Imaging (MPI)
- Interval between T99m-MPI and CardiacCath is within 30 days
- Females cannot be pregnant or lactating
Show all 9Show fewer
- Women of no child-bearing potential (post-menopausal defined as amenorrhea ≥ 12 consecutive months, or because they have undergone successful surgical sterilization and deny current history of pregnancy and nursing). These subjects do not require serum pregnancy test on the day of the study
- Women of childbearing potential will require a negative serum pregnancy test, performed on the day of the study
- Provide signed Informed Consent prior to undergoing the study procedures
Who cannot join
- Patients less than 18 and ≥89 years of age
- Patient has been involved in any other investigative, radioactive research procedure within 7 days and during the study participation period
- History of 2nd or 3rd degree Atrio-ventricular-block, or sinus node dysfunction unless the patients have a functioning artificial pacemaker
- Current ventricular tachycardia, atrial fibrillation, atrial tachycardia, or atrial flutter
- Current unstable angina or cardiovascular instability
- Current history of exacerbated Chronic Obstructive Pulmonary Disease (COPD) or asthma
- Known hypersensitivity or contraindication to regadenoson or aminophylline
- Use of caffeinated substance, dipyridamole-containing medication, aminophylline, or xanthines containing medication (e.g. theophylline) within the 12 hours prior to Lexiscan administration
About this study
Official title: Feasibility and Diagnostic Accuracy of Myocardial SPECT Using Early Imaging Protocol: A Pilot Study
Encouraged by the recent data published ,the investigators think that a waiting time of 10 minutes is feasible while preserving diagnostic accuracy and would like to assess the feasibility and diagnostic efficacy of W10 compared with W30 imaging in a pilot study. By combining W10 imaging with half-time acquisition, the time of the technetium-99m myocardial perfusion imaging procedure could be shortened by at least 50%, lasting only 40 minutes for W10 (10-minute waiting) imaging compared with 90 minutes for W30 imaging (30-minute waiting).
The investigators hypothesize that (1) W10 MPI is clinically feasible and tolerable by the patients, that (2) W10 MPI provides high image quality and that (3) W10 MPI provides diagnostic accuracy comparable to W30 MPI.
- Conditions
- Coronary Artery Disease, Atherosclerosis
- Being tested
- Myocardial Perfusion imaging with 10 minute waiting period
- Keywords
- Stable coronary artery disease
- Medical subject headings
- Coronary Artery Disease, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myocardial Perfusion imaging with 10 minute waiting periodProcedure or surgery
After the Myocardial Perfusion Imaging testing the investigators will wait 10 minutes to take images and then wait the 30 minute standard of care time to take images.
| Study group | Role | What they receive |
|---|---|---|
| 10/30 min rest/stress | No intervention | Rest and stress T99m-MPI obtained 10 minutes and 30 minutes after tracer injection. After the myocardial perfusion imaging the investigators will have 10 minute waiting period to take images and then wait the 30 minutes, standard of care to take the images. Receives: Procedure: Myocardial Perfusion imaging with 10 minute waiting period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual and semi-quantitative evaluation of W10 and W30 studies.
The investigators will evaluate image quality of W10 and W30-qualitatively (visually) by 2 independent readers and semi-qualitatively by means of region of interest (ROI) count/pixels parameters of W10 and W30 data and compare their diagnostic accuracy for the diagnosis of myocardial ischemia and infarction.
Measured: Day 1of testing
Secondary outcomes (2)
Tolerability Questionnaire
Each patient will complete a total of 6 questionnaires on the day of testing before and after each stress W10 and W30 scanning. The participants will be asked to rate how they felt, and if present, how they perceived their headache during scanning. Patients will also be asked how they felt and how severe was their headache when comparing the rest W10 and W30 and the stress W10 and W30.
Measured: Day 1 of testing
Feasibility of W10 by written documentation.
By documenting any technical or clinical difficulties during the W10 procedure
Measured: Day 1 of testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2014 (estimated)
- Study startDec 2015
- Primary completionApr 2016 (estimated)
- Study completionApr 2017 (estimated)
Why it stopped: Sponsor and site were unable to complete a final contract to support 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.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medhat Osman MD
- Sponsor type
- US federal agency
- Collaborators
- Astellas Pharma US, Inc.
- Responsible party
- Sponsor-investigator, Medhat Osman MD, VA St. Louis Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02136706
- Sponsor's protocol ID
- REGA-14A01
- Status last verified
- Dec 2015
- First submitted
- 4 May 2014
- Last updated
- 16 Dec 2015
- 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 16 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Diagnostic Accuracy of Myocardial SPECT Using Early Imaging Protocol: A Pilot Study
- ClinicalTrials.gov ID
- NCT02136706
- Acronym / sponsor ID
- REGA-14A01
- Conditions
- Coronary Artery Disease, Atherosclerosis
- Keywords
- Stable coronary artery disease
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor and site were unable to complete a final contract to support the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medhat Osman MDUS federal agency
- Collaborators
- Astellas Pharma US, Inc.
- Study start
- Dec 2015
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 13 May 2014 (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.
Encouraged by the recent data published ,the investigators think that a waiting time of 10 minutes is feasible while preserving diagnostic accuracy and would like to assess the feasibility and diagnostic efficacy of W10 compared with W30 imaging in a pilot study. By combining W10 imaging with half-time acquisition, the time of the technetium-99m myocardial perfusion imaging procedure could be shortened by at least 50%, lasting only 40 minutes for W10 (10-minute waiting) imaging compared with 90 minutes for W30 imaging (30-minute waiting).
The investigators hypothesize that (1) W10 MPI is clinically feasible and tolerable by the patients, that (2) W10 MPI provides high image quality and that (3) W10 MPI provides diagnostic accuracy comparable to W30 MPI.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 10/30 min rest/stress | No intervention | Procedure: Myocardial Perfusion imaging with 10 minute waiting periodRest and stress T99m-MPI obtained 10 minutes and 30 minutes after tracer injection. After the myocardial perfusion imaging the investigators will have 10 minute waiting period to take images and then wait the 30 minutes, standard of care to take the images. |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Men and women ≥18 and ≤ 89 years of age of any race /ethnicity
- Patient has undergone or is being scheduled for a clinically indicated CardiacCath with or without angioplasty
- Patient may have suffered myocardial infarction more than 3 days before T99m-MPI
- Patient may have undergone percutaneous transluminal coronary angioplasty (PTCA) or coronary stent placement more than 3 days prior to T99m-Myocardial Perfusion Imaging (MPI)
- Interval between T99m-MPI and CardiacCath is within 30 days
Key exclusion criteria (8 listed)
- Patients less than 18 and ≥89 years of age
- Patient has been involved in any other investigative, radioactive research procedure within 7 days and during the study participation period
- History of 2nd or 3rd degree Atrio-ventricular-block, or sinus node dysfunction unless the patients have a functioning artificial pacemaker
- Current ventricular tachycardia, atrial fibrillation, atrial tachycardia, or atrial flutter
- Current unstable angina or cardiovascular instability
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 with 10 minute waiting periodAfter the Myocardial Perfusion Imaging testing the investigators will wait 10 minutes to take images and then wait the 30 minute standard of care time to take images. | Procedure or surgery | 10/30 min rest/stress |
Primary outcome
Visual and semi-quantitative evaluation of W10 and W30 studies.
Time frame: Day 1of testing
The investigators will evaluate image quality of W10 and W30-qualitatively (visually) by 2 independent readers and semi-qualitatively by means of region of interest (ROI) count/pixels parameters of W10 and W30 data and compare their diagnostic accuracy for the diagnosis of myocardial ischemia and infarction.
2 secondary outcomes
Tolerability Questionnaire
Time frame: Day 1 of testing
Feasibility of W10 by written documentation.
Time frame: Day 1 of testing
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 16 Dec 2015.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Myocardial Perfusion imaging with 10 minute waiting period in people with Coronary Artery Disease and Atherosclerosis, run by Medhat Osman MD.
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 9 inclusion and 8 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 16 Dec 2015. 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?
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?
Visual and semi-quantitative evaluation of W10 and W30 studies. (time frame: Day 1of testing). 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 16 Dec 2015; AzTrials last refreshed its copy on 7 Nov 2026.