Cardiovascular DiseasesPhase 2NCT03103061
Use of Lexiscan for Myocardial Stress Perfusion Computed Tomography With a 3rd Generation Dual Source CT System
A Phase 2 study testing Lexiscan in people with Cardiovascular Diseases and Coronary Artery Disease, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the feasibility, tolerability, safety, and image quality of low-radiation, dynamic perfusion CT of the heart in patients with suspected ischemic chest pain and a moderate or severe stenosis seen on coronary CTA. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cardiovascular Diseases, Coronary Artery Disease
- What is being tested?
- Lexiscan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2016to 14 Jun 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must present with symptoms (e.g. chest pain) suspicious for cardiac ischemia as determined by treating physician.
- Subject must have been referred for cardiac CT angiography OR subject must have undergone clinically indicated SPECT with positive or equivocal findings OR subject must have undergone clinically indicated SPECT with prior cardiac CT angiography that showed moderate or severe stenosis.
- Subject must be 18 - 85 years of age.
- Subject must provide written informed consent prior to any study-related procedures being performed.
- Subject must be willing to comply with all clinical study procedures.
Who cannot join
- Subject is a pregnant or nursing female. Exclude the possibility of pregnancy:
- By testing (serum or urine beta HCG) within 24 hours before study agent administration, or
- By surgical sterilization, or
- Post menopausal, with minimum one (1) year history without menses.
- Subject has severe asthma or COPD requiring frequent inhaler use.
- Subject has prior diagnosis of obstructive CAD that has not been revascularized.
Show all 20Show fewer
- Subject with implanted rhythm devices (pacemaker, defibrillator).
- Subject has significant arrhythmia.
- Subject has high grade heart block.
- Subject has resting heart rate < 45 bpm, systolic blood pressure <90 mm Hg, or has consumed caffeine within the last 12 hours.
- Subject has an acute psychiatric disorder.
- Subject is unwilling to comply with the requirements of the protocol.
- Subject has previously entered this study.
- Subject has an allergy against iodinated contrast agents or pharmaceutical stressors used in this study.
- Subject suffers from claustrophobia.
- Subject has impaired renal function (creatinine > 1.5 mg/dl).
- Subject is in unstable condition.
- ST-elevations, new transient ST changes greater than 0.05mV or T- wave inversions with symptoms
- Subject cannot safely be administered Lexiscan™ per prescribing information as determined by investigator
- Subject has received interventional (PCI, stenting) or surgical (CABG) treatment that may alter the cardiac condition regarding myocardial perfusion status and/or stenosis degree between cardiac CTA, SPECT, and/or CT stress perfusion studies.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
The purpose of this study is to evaluate the feasibility, tolerability, safety, and image quality of low-radiation, dynamic perfusion CT of the heart in patients with suspected ischemic chest pain and a moderate or severe stenosis seen on coronary CTA. Secondary aims include the assessment of the diagnostic accuracy of CT perfusion imaging compared to either SPECT or invasive angiography.
- Conditions
- Cardiovascular Diseases, Coronary Artery Disease
- Being tested
- Lexiscan
- Keywords
- Computed Tomography
- Medical subject headings
- Cardiovascular Diseases, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LexiscanDrug
Coronary vasodilator
| Study group | Role | What they receive |
|---|---|---|
| Myocardial Stress CT Perfusion | Experimental | Low-radiation, dynamic perfusion CT of the heart in patients with suspected ischemic chest pain and a moderate or severe stenosis seen on coronary CTA. Lexiscan(TM) will be used as the pharmacological stress agent (coronary vasodilator). Receives: Drug: Lexiscan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Treatment-related Adverse Events
Demonstrate that CTA with stress and rest perfusion imaging using Lexiscan as the coronary vasodilator will be safe and well tolerated.
This outcome measure data value represents the number of adverse events that occurred during this study.
Measured: 30 days +/- 3 days
Secondary outcomes (1)
Diagnostic Accuracy Using Quantitative Objective Image Quality Assessment
Assess the diagnostic accuracy of CT perfusion imaging compared to either SPECT or invasive angiography.
Measured: Immediately following CT perfusion imaging.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2017
- Study start9 Feb 2016
- Primary completion14 Jun 2018
- Study completion14 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Stress and rest perfusion imaging using Lexiscan as the coronary vasodilator (pharmacological stressor).
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma US, Inc.
- Responsible party
- Principal investigator, U. Joseph Schoepf, MD, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03103061
- Sponsor's protocol ID
- Pro00051308
- Status last verified
- Jul 2019
- First submitted
- 28 Mar 2017
- Last updated
- 9 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Lexiscan for Myocardial Stress Perfusion Computed Tomography With a 3rd Generation Dual Source CT System
- ClinicalTrials.gov ID
- NCT03103061
- Acronym / sponsor ID
- Pro00051308
- Conditions
- Cardiovascular Diseases, Coronary Artery Disease
- Keywords
- Computed Tomography
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Astellas Pharma US, Inc.
- Study start
- 9 Feb 2016 (actual)
- Primary completion
- 14 Jun 2018 (actual)
- Study completion
- 14 Jun 2018 (actual)
- First posted
- 6 Apr 2017 (actual)
- Results
- Posted 9 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the feasibility, tolerability, safety, and image quality of low-radiation, dynamic perfusion CT of the heart in patients with suspected ischemic chest pain and a moderate or severe stenosis seen on coronary CTA. Secondary aims include the assessment of the diagnostic accuracy of CT perfusion imaging compared to either SPECT or invasive angiography.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Stress and rest perfusion imaging using Lexiscan as the coronary vasodilator (pharmacological stressor).
| Arm | Type | Receives |
|---|---|---|
| Myocardial Stress CT Perfusion | Experimental | Drug: LexiscanLow-radiation, dynamic perfusion CT of the heart in patients with suspected ischemic chest pain and a moderate or severe stenosis seen on coronary CTA. Lexiscan(TM) will be used as the pharmacological stress agent (coronary vasodilator). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject must present with symptoms (e.g. chest pain) suspicious for cardiac ischemia as determined by treating physician.
- Subject must have been referred for cardiac CT angiography OR subject must have undergone clinically indicated SPECT with positive or equivocal findings OR subject must have undergone clinically indicated SPECT with prior cardiac CT angiography that showed moderate or severe stenosis.
- Subject must be 18 - 85 years of age.
- Subject must provide written informed consent prior to any study-related procedures being performed.
- Subject must be willing to comply with all clinical study procedures.
Key exclusion criteria (20 listed)
- Subject is a pregnant or nursing female. Exclude the possibility of pregnancy:
- Subject has severe asthma or COPD requiring frequent inhaler use.
- Subject has prior diagnosis of obstructive CAD that has not been revascularized.
- Subject with implanted rhythm devices (pacemaker, defibrillator).
- Subject has significant arrhythmia.
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 |
|---|---|---|
| LexiscanCoronary vasodilator | Drug | Myocardial Stress CT Perfusion |
Primary outcome
Number of Treatment-related Adverse Events
Time frame: 30 days +/- 3 days
Demonstrate that CTA with stress and rest perfusion imaging using Lexiscan as the coronary vasodilator will be safe and well tolerated. This outcome measure data value represents the number of adverse events that occurred during this study.
1 secondary outcome
Diagnostic Accuracy Using Quantitative Objective Image Quality Assessment
Time frame: Immediately following CT perfusion imaging.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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?
A Phase 2 study testing Lexiscan in people with Cardiovascular Diseases and Coronary Artery Disease, run by Medical University of South Carolina at 1 site in United States.
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 20 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 9 Aug 2019. 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Treatment-related Adverse Events (time frame: 30 days +/- 3 days). 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 9 Aug 2019.