Use of Lexiscan for Myocardial Stress Perfusion Computed Tomography With a 3rd Generation Dual Source CT System
Study Details
Study Description
Brief 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. Secondary aims include the assessment of the diagnostic accuracy of CT perfusion imaging compared to either SPECT or invasive angiography.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Myocardial Stress CT Perfusion 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). |
Drug: Lexiscan
Coronary vasodilator
|
Outcome Measures
Primary Outcome Measures
- Number of Treatment-related Adverse Events [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.
Secondary Outcome Measures
- Diagnostic Accuracy Using Quantitative Objective Image Quality Assessment [Immediately following CT perfusion imaging.]
Assess the diagnostic accuracy of CT perfusion imaging compared to either SPECT or invasive angiography.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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.
Exclusion Criteria:
- 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.
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Medical University of South Carolina | Charleston | South Carolina | United States | 29425 |
Sponsors and Collaborators
- Medical University of South Carolina
- Astellas Pharma US, Inc.
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.- Pro00051308
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Standard Subject Enrollment |
|---|---|
| Arm/Group Description | Patients will undergo dynamic, stress perfusion computed tomography imaging during maximal hyperemia induced with Lexiscan™. CT MPI studies will use 40 - 50 mL of contrast agent (Ultravist 370) administered at a flow rate of 4 - 6 mL/s. Following the perfusion imaging, the Lexiscan™ will be reversed with 1 mg/kg of aminophylline per standard clinical protocol if indicated by the supervising physician. |
| Period Title: Overall Study | |
| STARTED | 24 |
| COMPLETED | 24 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Standard Subject Enrollment |
|---|---|
| Arm/Group Description | Patients will undergo dynamic, stress perfusion computed tomography imaging during maximal hyperemia induced with Lexiscan™. CT MPI studies will use 40 - 50 mL of contrast agent (Ultravist 370) administered at a flow rate of 4 - 6 mL/s. Following the perfusion imaging, the Lexiscan™ will be reversed with 1 mg/kg of aminophylline per standard clinical protocol if indicated by the supervising physician. |
| Overall Participants | 24 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
24
100%
|
| >=65 years |
0
0%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
17
70.8%
|
| Male |
7
29.2%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
6
25%
|
| White |
18
75%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
0
0%
|
| Region of Enrollment (participants) [Number] | |
| United States |
24
100%
|
Outcome Measures
| Title | Number of Treatment-related Adverse Events |
|---|---|
| Description | 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. |
| Time Frame | 30 days +/- 3 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Standard Subject Enrollment |
|---|---|
| Arm/Group Description | Patients will undergo dynamic, stress perfusion computed tomography imaging during maximal hyperemia induced with Lexiscan™. CT MPI studies will use 40 - 50 mL of contrast agent (Ultravist 370) administered at a flow rate of 4 - 6 mL/s. Following the perfusion imaging, the Lexiscan™ will be reversed with 1 mg/kg of aminophylline per standard clinical protocol if indicated by the supervising physician. |
| Measure Participants | 24 |
| Number [Adverse events] |
6
|
| Title | Diagnostic Accuracy Using Quantitative Objective Image Quality Assessment |
|---|---|
| Description | Assess the diagnostic accuracy of CT perfusion imaging compared to either SPECT or invasive angiography. |
| Time Frame | Immediately following CT perfusion imaging. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Standard Subject Enrollment |
|---|---|
| Arm/Group Description | Patients will undergo dynamic, stress perfusion computed tomography imaging during maximal hyperemia induced with Lexiscan™. CT MPI studies will use 40 - 50 mL of contrast agent (Ultravist 370) administered at a flow rate of 4 - 6 mL/s. Following the perfusion imaging, the Lexiscan™ will be reversed with 1 mg/kg of aminophylline per standard clinical protocol if indicated by the supervising physician. |
| Measure Participants | 24 |
| Sensitivity |
85.7
|
| Specificity |
70.6
|
| Accuracy |
75
|
Adverse Events
| Time Frame | 30 days +/- 3 days | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Standard Subject Enrollment | |
| Arm/Group Description | This study will plan to include 100 adults who present to the MUSC ED, hospital, or outpatient clinic with a clinical history and symptoms suspicious for cardiac ischemia and who have undergone or will likely undergo nuclear stress testing (SPECT). Patients who have been referred for a coronary CTA performed as part of a standard clinical evaluation determined by the treating physician(s) will be eligible for the study and recruited from the MUSC CT schedule. Before the patient comes in for their clinical coronary CTA, their cardiologist or primary physician will be contacted to ensure patient interest in the study and willingness to be approached. Willing patients will be approached and will undergo the informed consent process. | |
All Cause Mortality |
||
| Standard Subject Enrollment | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/24 (0%) | |
Serious Adverse Events |
||
| Standard Subject Enrollment | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/24 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Standard Subject Enrollment | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/24 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Hunter Gray, Program Coordinator |
|---|---|
| Organization | Medical University of South Carolina |
| Phone | 843-876-3185 |
| grayhu@musc.edu |
- Pro00051308