Absolute Quantification of Coronary Flow Reserve by Stress Perfusion MRI

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Northwestern University.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Astellas Pharma Global Development, Inc.
Information provided by (Responsible Party):
James Carr, Northwestern University
ClinicalTrials.gov Identifier:
NCT01655043
First received: July 30, 2012
Last updated: August 1, 2012
Last verified: August 2012
  Purpose

Coronary artery disease (CAD, coronary heart disease) is the leading cause of death in the U.S., causing 1 in 5 deaths in 2005. The current method for diagnosing coronary artery disease that is considered most accurate is coronary angiography however it involves risk and radiation. Alternatively nuclear imaging test and MRI stress test only permits the semi qualitative analysis of the myocardial perfusion images.

In this proposal the investigators will develop a means to calculate Coronary Flow Reserve (CFR) using the MRI. the investigators approach has the potential to reduce mortality from myocardial infarction by effecting a change in the patient management paradigm. Absolute quantification of myocardial perfusion will detect coronary stenosis and CAD in patients with more accuracy than the semi-quantitative or qualitative analysis of perfusion images. Measurement of Coronary Flow Reserve is important for the following reasons: decrease of coronary flow reserve has been identified as a first effect of CAD; it provides an objective measure of treatment efficacy.

The purpose of this study is to compare images from nuclear stress test and/or coronary angiography with Magnetic Resonance Imaging (MRI) that will evaluate subjects with coronary artery disease calculating myocardial blood flow using a novel MRI technique combined to an extracellular Gadolinium-based contrast agent and stressor agent


Condition Intervention Phase
Myocardial Ischemia
Drug: Regadenoson
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Absolute Quantification of Coronary Flow Reserve by Stress Perfusion MRI

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Quantification of myocardial blood volume [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    The investigators anticipate that a novel MRI imaging protocol using a high relaxivity blood-pool contrast agent (gadofosveset trisodium) is capable of quantifying coronary flow reserve based on quantification of myocardial blood volume and is strongly correlated with myocardial flow reserve as measured in low spatial resolution nuclear SPECT scans. Pre- and post- gadofosveset trisodium images will be used to calculate the myocardial blood volume (in ml/100g of tissue).


Secondary Outcome Measures:
  • Coronary Blood Volume calculation using MRI stress perfusion [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    The investigators anticipate that CBV changes (in ml/100g of tissue) under stress reflect complementary physiologic feed back to stress perfusion scans, contrary to the hypothesis by many groups who claim that cardiac BOLD and/or rest-perfusion scans can determine without recourse to exercise or pharmacological stress.


Estimated Enrollment: 20
Study Start Date: August 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Regadenoson
Patients will undergo MRI stress perfusion scan using Regadenoson as stressor agent and contrast agent (as standard of care) to quantifying coronary flow reserve based on quantification of myocardial blood volume.
Drug: Regadenoson
Regadenoson will be infused intravenously 0.4 mg/5 mL (0.08 mg/mL) as a single bolus.
Other Name: Lexiscan

Detailed Description:

The main hypothesis the investigators will test is that changes in myocardial blood volume, under physiologic stress, correlate with myocardial flow reserve as measured in low spatial resolution nuclear SPECT scans. Secondary hypothesis is that stress perfusion as quantified with bolus height corrected gadofosveset trisodium images, better correlate with SPECT perfusion than uncorrected, relative perfusion values.

The investigators propose implementing the scan protocol using a 1.5T or 3.0T MRI scanner. The investigators will scan a series of 20 patients recruited from the nuclear stress lab at Northwestern Memorial Hospital. These subjects will be approached and enrolled into a HIPPA Compliant, IRB approved research study to assess the effectiveness of myocardial perfusion and blood volume images to measure myocardial blood volume. Subjects will be scanned with a modified version of the clinical stress-perfusion protocol. Correlation analysis will be used to test the hypothesis that quantitative blood volume is an indicator of myocardial flow reserve.

  Eligibility

Ages Eligible for Study:   19 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Under an Institutional Committee on Human Research board approved protocol, 20 patients with a suspected myocardial ischemic disease with positive stress nuclear medicine test laboratory will be recruited in this prospective study. All subjects will be screened for GFR within 24 hours before the exam. All patients must have a GFR > 30 mL/min/1.73m2 to be included in the study.

All subjects will be selected following the Nephrogenic Systemic Fibrosis (NSF) guidelines. All dialysis patients or end-stage renal disease patients with a creatinine clearance of < 30mL/min will not be selected for the study to avoid NSF.

Exclusion Criteria:

  1. Age 18 to 89 years;
  2. Known contraindication to MR imaging (such as pacemaker placement, magnetic implants, etc);
  3. Claustrophobia;
  4. Inability to perform an adequate breath-hold for imaging,
  5. Inability to provide informed consent;
  6. all subjects will be will be screened for GFR within 24 hours before the exam and subjects presenting with GFR < 60 ml/min will be excluded;
  7. Pregnant and lactating women;
  8. Patients with hypersensitivity to gadolinium contrast agents, metoprolol, adenosine, or nitroglycerin;

10) Contra indication for Regadenoson

  1. 2nd- or 3rd-degree AV block (except in patients with a functioning artificial pacemaker)
  2. Sinus node disease (except in patients with a functioning artificial pacemaker)
  3. Unstable angina
  4. Acute myocardial infarction
  5. Known or suspected bronchoconstrictive or bronchospastic lung disease (e.g., asthma)
  6. Hypersensitivity to adenosine
  7. Caffeine within 12-24 hours
  8. Theophylline and Dipyridamole products within 24 hours
  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: NCT01655043

Contacts
Contact: James C Carr, MD 312-695-4218 jcarr@northwestern.edu
Contact: Kristyn Contreras, BS 312-926-4251 k-contreras@northwestern.edu

Locations
United States, Illinois
Northwestern University Not yet recruiting
Chicago, Illinois, United States, 60611
Contact: James C Carr, MC    312-695-4218    jcarr@northwestern.edu   
Sponsors and Collaborators
Northwestern University
Astellas Pharma Global Development, Inc.
Investigators
Principal Investigator: James C Carr, MD Northwestern University
  More Information

Publications:
Responsible Party: James Carr, director of cardiovascular imaging, Northwestern University
ClinicalTrials.gov Identifier: NCT01655043     History of Changes
Other Study ID Numbers: STU00050900, 000598
Study First Received: July 30, 2012
Last Updated: August 1, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Northwestern University:
Magnetic Resonance Imaging
regadenoson

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

ClinicalTrials.gov processed this record on September 30, 2014