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Whole-Heart Myocardial Blood Flow Quantification Using MRI

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ClinicalTrials.gov Identifier: NCT03064295
Recruitment Status : Recruiting
First Posted : February 27, 2017
Last Update Posted : March 13, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Debiao Li, PhD, Cedars-Sinai Medical Center

Brief Summary:

This study hopes to provide significant technical improvement in a Myocardial Blood Flow (MBF) cardiac magnetic resonance (CMR) quantification technique to address challenges and technical limitations for MBF CMR. By developing and validating novel techniques to improve first-pass perfusion (FPP) cardiac MR, we propose to increase diagnostic accuracy by minimizing false positives and false negatives, allow for better evaluation and accurate quantification of total ischemic burden and reduce image and motion-induced artifacts.

The broad, long-term objective of the proposed project is to improve the prognosis of patients with myocardial ischemia caused by coronary artery disease (CAD) or coronary microvascular dysfunction (CMD).


Condition or disease Intervention/treatment
Coronary Artery Disease Coronary Microvascular Disease Device: Myocardial Perfusion Cardiac MRI. Drug: Contrast Drug: Pharmacologic Stress Agent

Detailed Description:
All subjects will receive cardiac MRI scans to diagnose CAD or CMD. MR perfusion scans will be performed twice per subject: once at rest, and once after administration of a pharmacologic stress agent. There will be a >15 minute delay between the two scans. A gadolinium-based contrast agent will be administered during each scan to allow measurement of myocardial blood flow. Once myocardial blood flow is quantified, the measurements will be compared to previous reference measurements (when available) from PET myocardial perfusion imaging in the CAD patient cohort and coronary reactivity testing (CRT) in the CMD patient cohort.

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Study Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Whole-Heart Myocardial Blood Flow Quantification Using Magnetic Resonance Imaging
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : January 1, 2025
Estimated Study Completion Date : January 1, 2025

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Healthy Volunteers
60 healthy male or female (18 or older) adults will receive Myocardial Perfusion Cardiac MRI, including administration of contrast and a pharmacologic stress agent
Device: Myocardial Perfusion Cardiac MRI.
MRI with administration of a contrast drug and a stress agent, if no contraindications are present. The gadolinium based contrast agent to be used in this study is either Gadavist (up to 0.2 mL/kg body weight (0.2 mmol/kg) or MultiHance (0.2 mmol/kg) The IV stress agent is regadenoson (0.4mg/5ml bolus) or adenosine (dosage based on subject's weight and is set at 140mcg/kg/min
Other Names:
  • Myocardial Perfusion imaging
  • Myocardial Perfusion CMR
  • Magnetic Resonance Imaging
  • First Pass Myocardial Perfusion Imaging

Drug: Contrast
The intravenous gadolinium based contrast agent to be used in this study is either Gadavist (up to 0.2 mL/kg body weight (0.2 mmol/kg) or MultiHance (0.2 mmol/kg)
Other Names:
  • contrast media
  • Gadavist
  • MultiHance

Drug: Pharmacologic Stress Agent
The stress agent administered intravenously is regadenoson (0.4mg/5ml bolus) or adenosine (dosage based on subject's weight and is set at 140mcg/kg/min
Other Names:
  • regadenoson
  • adenosine
  • stress agent

CAD Patients
110 male or female adults (18 or older) who have undergone clinical myocardial perfusion imaging at CSMC and been diagnosed with Coronary Disease (CAD) will receive Myocardial Perfusion Cardiac MRI, including administration of contrast and a pharmacologic stress agent.
Device: Myocardial Perfusion Cardiac MRI.
MRI with administration of a contrast drug and a stress agent, if no contraindications are present. The gadolinium based contrast agent to be used in this study is either Gadavist (up to 0.2 mL/kg body weight (0.2 mmol/kg) or MultiHance (0.2 mmol/kg) The IV stress agent is regadenoson (0.4mg/5ml bolus) or adenosine (dosage based on subject's weight and is set at 140mcg/kg/min
Other Names:
  • Myocardial Perfusion imaging
  • Myocardial Perfusion CMR
  • Magnetic Resonance Imaging
  • First Pass Myocardial Perfusion Imaging

Drug: Contrast
The intravenous gadolinium based contrast agent to be used in this study is either Gadavist (up to 0.2 mL/kg body weight (0.2 mmol/kg) or MultiHance (0.2 mmol/kg)
Other Names:
  • contrast media
  • Gadavist
  • MultiHance

Drug: Pharmacologic Stress Agent
The stress agent administered intravenously is regadenoson (0.4mg/5ml bolus) or adenosine (dosage based on subject's weight and is set at 140mcg/kg/min
Other Names:
  • regadenoson
  • adenosine
  • stress agent

CMD Patients
50 female adults (21 or older) who have undergone coronary reactivity testing at CSMC and been diagnosed with coronary microvascular disease (CMD) will receive Myocardial Perfusion Cardiac MRI, including administration of contrast and a pharmacologic stress agent.
Device: Myocardial Perfusion Cardiac MRI.
MRI with administration of a contrast drug and a stress agent, if no contraindications are present. The gadolinium based contrast agent to be used in this study is either Gadavist (up to 0.2 mL/kg body weight (0.2 mmol/kg) or MultiHance (0.2 mmol/kg) The IV stress agent is regadenoson (0.4mg/5ml bolus) or adenosine (dosage based on subject's weight and is set at 140mcg/kg/min
Other Names:
  • Myocardial Perfusion imaging
  • Myocardial Perfusion CMR
  • Magnetic Resonance Imaging
  • First Pass Myocardial Perfusion Imaging

Drug: Contrast
The intravenous gadolinium based contrast agent to be used in this study is either Gadavist (up to 0.2 mL/kg body weight (0.2 mmol/kg) or MultiHance (0.2 mmol/kg)
Other Names:
  • contrast media
  • Gadavist
  • MultiHance

Drug: Pharmacologic Stress Agent
The stress agent administered intravenously is regadenoson (0.4mg/5ml bolus) or adenosine (dosage based on subject's weight and is set at 140mcg/kg/min
Other Names:
  • regadenoson
  • adenosine
  • stress agent




Primary Outcome Measures :
  1. CAD findings by MRI [ Time Frame: Day One ]
    Accuracy (sensitivity and specificity) of MRI-based diagnosis of coronary artery disease (CAD) as compared to PET.

  2. CMD findings by MRI [ Time Frame: Day One ]
    Accuracy (sensitivity and specificity) of MRI-based diagnosis of coronary microvascular dysfunction (CMD), as compared to CRT.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   CMD cohort will enroll female participants only.
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
  • 60 healthy male or female (18 or older) participants
  • 110 male or female adults (18 or older) who have undergone clinical myocardial perfusion imaging at CSMC and been diagnosed with Coronary Disease (CAD).
  • 50 female adults (21 or older) who have undergone coronary reactivity testing at CSMC and been diagnosed with coronary microvascular disease (CMD).
Criteria

Inclusion Criteria:

  • 60 healthy male or female (18 or older) participants
  • 110 male or female adults (18 or older) who have undergone clinical myocardial perfusion imaging at CSMC and been diagnosed with Coronary Disease (CAD).
  • 50 female adults (21 or older) who have undergone coronary reactivity testing at CSMC and been diagnosed with coronary microvascular disease (CMD).

Exclusion Criteria:

  • MR imaging is contraindicated in persons with mechanically, magnetically, or electrically activated implants, such as cardiac pacemakers, neurostimulators, and infusion pumps.
  • Persons with ferromagnetic implants and ferromagnetic foreign bodies, such as intracranial, aneurysm clips, shrapnel and intraocular metal chips as these could become dislodged.
  • Patients who are pregnant, nursing, implanted with non MR-compatible intrauterine devices (IUD's)
  • Persons unable to tolerate MRI imaging secondary to an inability to lie supine or severe claustrophobia.
  • Persons who are non-compliant with visit instructions, including inability to lie still, hold breath or follow procedure instructions
  • Persons whose renal function test does not meet CSMC standard of care MRI contrast protocol requirements (GFR <45ml/min).
  • Persons with stated allergy to animal dander
  • acute coronary syndrome or acute myocardial infarction or ongoing myocardial ischemia or ECG evidence of ongoing ischemia;
  • patients with concurrent cardiogenic shock or requiring inotropic or intra-aortic balloon support or prior/planned PCI or CABG;
  • non-ischemic cardiomyopathy or more than moderate valvular disease;
  • contraindication to stress agent (adenosine) including asthma or prior adverse reaction to adenosine
  • contraindications for gadolinium contrast;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03064295


Contacts
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Contact: Johanna Kim, MPH 310 248-8668 johanna.kim@cshs.org

Locations
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United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Principal Investigator: Zhaoyang Fan, PhD         
Sponsors and Collaborators
Cedars-Sinai Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Zhaoyang Fan, PhD Cedars-Sinai Medical Center

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Responsible Party: Debiao Li, PhD, Director, Biomedical Imaging Research Institute, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT03064295     History of Changes
Other Study ID Numbers: 42972
1R01HL124649 ( U.S. NIH Grant/Contract )
First Posted: February 27, 2017    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Adenosine
Regadenoson
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Vasodilator Agents
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adenosine A2 Receptor Agonists