Artifact-Free High-Resolution Myocardial Perfusion MRI in Subjects With Abnormal Nuclear Myocardial Perfusion Studies

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Cedars-Sinai Medical Center
Sponsor:
Collaborator:
Astellas Pharma US, Inc.
Information provided by (Responsible Party):
Daniel S. Berman, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT01949844
First received: September 11, 2013
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

This is a pilot study in a patient population with suspected Coronary Artery Disease CAD) as defined by the presence of an abnormal nuclear (PET/SPECT) 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 a novel MR technique for localization of perfusion deficits in comparison to PET/SPECT.

This is not a study to specifically evaluate the efficacy or safety of the drugs but rather the diagnostic accuracy of the cardiac MRI procedure as a whole


Condition Intervention
Coronary Artery Disease
CAD
Drug: regadenoson
Drug: Optimark®
Device: Myocardial perfusion MRI

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Artifact-Free High-resolution Myocardial Perfusion MRI in Subjects With Abnormal Nuclear Myocardial Perfusion Studies

Resource links provided by NLM:


Further study details as provided by Cedars-Sinai Medical Center:

Primary Outcome Measures:
  • Presence and severity of perfusion deficit on images [ Time Frame: baseline only ] [ Designated as safety issue: No ]
    Presence and severity of myocardial perfusion deficit on MR and PET/SPECT scans as assessed by blinded readers on a 4-point scale from none to severe.


Estimated Enrollment: 44
Study Start Date: May 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Suspected or known CAD
Myocardial Perfusion MRI with administration of gadolinium contrast(Optimark®)and vasodilator(regadenoson used off-label)
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 Name: Lexiscan®
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:
  • gadoversetamide
  • gadolinium
  • MRI contrast agent
  • gadolinium contrast
Device: Myocardial perfusion MRI
.
Other Names:
  • magentic resonance imaging
  • ischemia
  • cardiac blood flow
  • perfusion

Detailed Description:

A total of 2 imaging protocols will be used in this study: (1) One-day SPECT protocol, which involves the subjects undergoing stress myocardial perfusion SPECT and MRI in the same day; (2) Two-day PET/SPECT protocol, which involves MRI of subjects who have had a recent abnormal PET/SPECT study and includes an optional second-day visit.

Two blinded readers will interpret MR and SPECT/PET studies by consensus to assess the presence of perfusion deficits at stress and rest.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults ≥ 18 years of age
  • Clinically stable individuals with suspected or known coronary artery disease
  • Clinically indicated stress PET/SPECT study with mild to moderate ischemia or prior myocardial infarction AND a visual scan interpretation of definitely abnormal; or, clinically indicated stress SPECT study with either prior myocardial infarction or prior abnormal SPECT/PET study and no intervening revascularization since the prior study.

Exclusion Criteria:

  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01949844

Contacts
Contact: Behzad Sharif, PhD 310 423-7758 behzad.sharif@cshs.org
Contact: Daniel S Berman, MD 310 423-4387 bermand@cshs.org

Locations
United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Behzad Sharif, PhD    310-423-7758    behzad.sharif@cshs.org   
Principal Investigator: Daniel S Berman, MD         
Sponsors and Collaborators
Daniel S. Berman
Astellas Pharma US, Inc.
Investigators
Principal Investigator: Daniel S Berman, MD Cedars-Sinai Medical Center
  More Information

No publications provided

Responsible Party: Daniel S. Berman, Chief, Cardiac Imaging / Nuclear Cardiology, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT01949844     History of Changes
Other Study ID Numbers: 28466
Study First Received: September 11, 2013
Last Updated: April 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Cedars-Sinai Medical Center:
MRI
Magnetic Resonance Imaging
myocardial perfusion
myocardial perfusion imaging
Novel MRI Techniques

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Contrast Media
Regadenoson
Diagnostic Uses of Chemicals
Pharmacologic Actions
Adenosine A2 Receptor Agonists
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 29, 2014