Artifact-Free High-Resolution Myocardial Perfusion MRI in Subjects With Abnormal Nuclear Myocardial Perfusion Studies
Study Details
Study Description
Brief Summary
This is a pilot study in a patient population with suspected coronary artery disease (CAD) as defined by the presence of a prior abnormal nuclear (PET/SPECT) myocardial perfusion scan. In this study design, PET/SPECT will serve as the comparative standard for presence of myocardial ischemia. We intend to determine the accuracy of an improved magnetic resonance imaging (MRI) technique for detection of myocardial ischemia in subjects with suspected CAD.
This is not a study to specifically evaluate the efficacy or safety of the drugs but rather the diagnostic performance of the improved cardiac MRI procedure.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
A total of two imaging protocols will be used as "protocol options" in this study (only one of the protocols will be used for each enrolled subject): (1) "Two-day protocol," which involves MRI of subjects who have had a recent abnormal PET/SPECT study and includes an optional second-day visit; (2) "One-day protocol," which involves the subjects undergoing stress myocardial perfusion SPECT and MRI in the same day.
Two blinded readers will interpret MR and SPECT/PET studies by consensus to assess the presence of perfusion deficits at stress and rest.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Suspected coronary artery disease (CAD) This pilot study has a single arm/group of subjects with suspected CAD based on the following inclusion criteria: Prior nuclear myocardial perfusion scan (PET/SPECT) with a visual interpretation of definitely abnormal, or prior myocardial infarction; or, Clinically stable individuals with suspected coronary artery disease on the basis of coronary angiography. The study protocol involved only a myocardial perfusion MRI procedure for detection of ischemia (perfusion deficits) using an improved protocol with the administration of a vasodilator drug (Regadenoson/Lexiscan®) and gadolinium-based MRI contrast agent (Optimark®; dose: 0.2 mmol/kg). Lexiscan® was used off-label as a vasodilator drug during the MRI scan (0.4 mg/5mL) supplied by the manufacturer, Astellas Pharma U.S. |
Drug: regadenoson
Lexiscan® is being used off-label. The FDA Issued IND # is 119898. For the cardiac MRI, Lexiscan® will be used at the same dosage and administration as prescribed in the package insert - 5 mL (0.4 mg regadenoson) as packaged and supplied by the manufacturer, Astellas Pharma U.S., in single-use pre-filled syringes administered by rapid intravenous injection, followed immediately by saline flush.
Other Names:
Drug: Optimark®
For the cardiac MR, the contrast agent, Optimark® is administered as a bolus peripheral intravenous injection at a dose of 0.2 mL/kg (0.1 mmol/kg) and at a rate of 1 to 2 mL/sec delivered by manual injection.
Other Names:
Device: Myocardial perfusion MRI
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Diagnostic Performance (Specificity and Sensitivity) for Detection of Myocardial Perfusion Deficits on Magnetic Resonance (MR) Images [Baseline only]
In this study, the approach is to use nuclear myocardial perfusion (prior PET/SPECT scans for the enrolled patients) as the comparative standard for detection of myocardial ischemia (presence of perfusion deficits). Using this approach, the acquired MR images will be analyzed to determine the diagnostic performance (specificity and sensitivity) of the improved MRI technique for detection of myocardial perfusion deficits.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Clinically indicated nuclear myocardial perfusion (PET/SPECT) study with mild to moderate ischemia or prior myocardial infarction AND a visual scan interpretation of definitely abnormal AND no intervening revascularization since the prior study; or,
-
Clinically stable individuals with suspected or known coronary artery disease on the basis of coronary angiography.
Exclusion Criteria:
-
< 18 years of age
-
Hypotension (systolic blood pressure <100 mm Hg)
-
Significant non-coronary cardiac disease (e.g. severe valvular abnormality, significant cardiomyopathy, etc.)
-
Persons unable to successfully pass MRI health and safety screening
-
Persons whose renal function test does not meet CSMC standard of care MRI contrast protocol requirements (GFR <45 ml/min based on serum creatinine, age, gender, and ethnicity).
-
Subjects with contraindications to or intolerance of regadenoson.
-
Persons with an allergy to gadolinium-based contrast.
-
Persons with a history of kidney or liver disease.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cedars-Sinai Medical Center | Los Angeles | California | United States | 90048 |
Sponsors and Collaborators
- Daniel S. Berman
- Astellas Pharma US, Inc.
Investigators
- Principal Investigator: Daniel S Berman, MD, Cedars-Sinai Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 28466
Study Results
Participant Flow
| Recruitment Details | A total of 44 subjects with suspected coronary artery disease defined based on prior abnormal nuclear myocardial perfusion (PET/SPECT) scan or prior abnormal coronary angiogram were recruited at Cedars-Sinai Medical Center (CSMC) in Los Angeles, CA. |
|---|---|
| Pre-assignment Detail | This pilot study did not involve evaluation of the efficacy of a drug but rather the diagnostic performance of an improved cardiac magnetic resonance imaging (MRI) technique for detection of myocardial ischemia (presence of perfusion deficits) in subjects with suspected coronary artery disease. |
| Arm/Group Title | Suspected Coronary Artery Disease (CAD) |
|---|---|
| Arm/Group Description | This pilot study involved a single arm/group of subjects with suspected CAD who all underwent cardiac magnetic resonance imaging (MRI) based on the following inclusion criteria: Prior nuclear myocardial perfusion (PET/SPECT) scan with a visual interpretation of definitely abnormal, or prior myocardial infarction; or, Clinically stable individuals with suspected coronary artery disease on the basis of coronary angiography. Study Protocol: MRI for detection of perfusion deficits using an improved technique with the administration of a vasodilator drug (Regadenoson) and gadolinium-based MRI contrast agent (with standard dose of 0.2 mmol/kg). Vasodilator drug (Regadenoson) used in the study: Lexiscan® (FDA-issued IND# 119898) was used off-label as a vasodilator drug during the cardiac MRI scan as prescribed in the package insert (0.4 mg/5mL bolus followed by saline flush) supplied by the manufacturer, Astellas Pharma U.S., in single-use pre-filled syringes. |
| Period Title: Overall Study | |
| STARTED | 44 |
| COMPLETED | 44 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Suspected Coronary Artery Disease (CAD) |
|---|---|
| Arm/Group Description | This pilot study involved a single arm/group of subjects with suspected CAD who were recruited to undergo an improved cardiac magnetic resonance imaging (MRI) protocol with vasodilator stress (Regadenoson) for detection of myocardial perfusion defects. All subjects were recruited based on the following inclusion criteria: (a) prior nuclear myocardial perfusion (PET/SPECT) scan with a visual interpretation of definitely abnormal, or prior myocardial infarction; or, (b) clinically stable individuals with suspected coronary artery disease on the basis of invasive or noninvasive coronary angiography. |
| Overall Participants | 44 |
| Overall Count of Participants | 44 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
21
47.7%
|
| >=65 years |
23
52.3%
|
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
65
(11)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
10
22.7%
|
| Male |
34
77.3%
|
| Region of Enrollment (Count of Participants) | |
| United States |
44
100%
|
Outcome Measures
| Title | Diagnostic Performance (Specificity and Sensitivity) for Detection of Myocardial Perfusion Deficits on Magnetic Resonance (MR) Images |
|---|---|
| Description | In this study, the approach is to use nuclear myocardial perfusion (prior PET/SPECT scans for the enrolled patients) as the comparative standard for detection of myocardial ischemia (presence of perfusion deficits). Using this approach, the acquired MR images will be analyzed to determine the diagnostic performance (specificity and sensitivity) of the improved MRI technique for detection of myocardial perfusion deficits. |
| Time Frame | Baseline only |
Outcome Measure Data
| Analysis Population Description |
|---|
| Patients who did not have diagnostically interpretable MRI data were not analyzed. |
| Arm/Group Title | Suspected Coronary Artery Disease (CAD) |
|---|---|
| Arm/Group Description | This pilot study has a single arm/group of subjects with suspected CAD based on the following inclusion criteria: Prior nuclear myocardial perfusion scan (PET/SPECT) with a visual interpretation of definitely abnormal, or prior myocardial infarction; or, Clinically stable individuals with suspected coronary artery disease on the basis of coronary angiography. The study protocol involved only a myocardial perfusion MRI procedure for detection of ischemia (perfusion deficits) using an improved protocol with the administration of a vasodilator drug (Regadenoson/Lexiscan®) and gadolinium-based MRI contrast agent (Optimark®; dose: 0.2 mmol/kg). Lexiscan® was used off-label as a vasodilator drug during the MRI scan (0.4 mg/5mL) supplied by the manufacturer, Astellas Pharma U.S. |
| Measure Participants | 38 |
| diagnostic sensitivity |
95
|
| diagnostic specificity |
94
|
Adverse Events
| Time Frame | Duration of the visit to the medical center for undergoing the cardiac magnetic resonance imaging study (1 day). | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Suspected Coronary Artery Disease (CAD) | |
| Arm/Group Description | This pilot study involved a single arm/group of subjects with suspected CAD who were recruited to undergo an improved cardiac magnetic resonance imaging (MRI) protocol with vasodilator stress (Regadenoson) for detection of myocardial perfusion defects. All subjects were recruited based on the following inclusion criteria: (a) prior nuclear myocardial perfusion scan with a visual interpretation of definitely abnormal, or prior myocardial infarction; or, (b) clinically stable individuals with suspected coronary artery disease on the basis of invasive or noninvasive coronary angiography. | |
All Cause Mortality |
||
| Suspected Coronary Artery Disease (CAD) | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Suspected Coronary Artery Disease (CAD) | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/44 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Suspected Coronary Artery Disease (CAD) | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/44 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE 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 | Dr. Behzad Sharif, Assistant Professor |
|---|---|
| Organization | Cedars-Sinai Medical Center |
| Phone | 310-423-7758 |
- 28466