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Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System

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ClinicalTrials.gov Identifier: NCT03331380
Recruitment Status : Recruiting
First Posted : November 6, 2017
Last Update Posted : February 28, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

Brief Summary:

Background:

Researchers are testing a new kind of magnetic resonance imaging (MRI) scanner to take pictures of the heart. It uses lower energy levels than other MRI scanners. This may help scan people with metal devices in their body, or in invasive heart procedures using metal tools.

Objective:

To test new MRI scanners and software changes to create better pictures of the heart.

Eligibility:

People with heart disease and healthy volunteers, ages 18 and older

Design:

Participants will be screened with blood tests.

Participants with heart disease will have both the new MRI and a conventional MRI. Healthy participants will have both MRIs or only the new one. If 2 are done, they must be within 60 days.

For both MRI versions, participants lie on a table that slides into a large tube. During scans, they will hold their breath for up to 20 seconds at a time. Heart activity will be measured by wires connected to pads on the skin. A flexible belt may be used to monitor their breathing. They will be in the scanner up to 2 hours.

Participants can agree to have a dye called gadolinium injected into their arm during the scan. This brightens the pictures of the heart.

Participants can agree to take a drug called a vasodilator. This helps detect areas of the heart with abnormal blood supply. Scans of the heart are taken before, during, and after they get the medicine. The drug may cause temporary chest pain or shortness of breath. They may get other drugs to relieve these symptoms.

Sponsoring Institution: National Heart, Lung, and Blood Institute


Condition or disease Intervention/treatment Phase
CAD Device: MRI scan x 1- Healthy volunteer Device: MRI scan x 2- Healthy volunteer Device: MRI scan x 2- CAD patients Device: MRI scan x 2- non-CAD patients Phase 1 Phase 2

Detailed Description:

Cardiac magnetic resonance imaging (CMR) provides accurate and reproducible measures of cardiac chamber volumes, cardiac function, blood flow, myocardial scar, myocardial extracellular volume as a measure of collagen content, myocardial iron content, and others, all without exposure to ionizing radiation. The prevailing wisdom is that CMR using high specific absorption rate (SAR) scanning modes produces highest image quality. We propose a method of CMR that can be performed with low SAR but that nevertheless preserves image quality because of efficient use of CMR signal. CMR using low SAR is attractive because it may reduce heating of metallic structures. This may allow safe CMR in patients with metallic implants, and it may allow MRI catheterization using metallic guidewires and catheter devices.

The goal of this non-significant risk (NSR) medical device study is to test initial technical feasibility of low SAR CMR in healthy volunteers by technical optimization of scanner protocols, to test comparative accuracy of standard CMR measurements in healthy volunteers using low SAR CMR versus conventional CMR, and to test comparative accuracy of standard CMR measurements in adult patients with known stable heart disease using low SAR CMR versus conventional CMR.

A secondary goal is to assess the potential of this new low-SAR CMR system to perform non-cardiovascular radiological diagnostic imaging by testing comparative diagnostic accuracy of standard MR measurements in adult patients with known non-cardiovascular disease using the low SAR CMR system vs conventional MR exam.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System
Actual Study Start Date : January 5, 2018
Estimated Primary Completion Date : May 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

Arm Intervention/treatment
Group A
Group A includes 150 healthy adult volunteers of both sexes with-out known cardiovascular disease; MRI Scan x 1 for 60 healthy volunteers; MRI Scan x 2 in 60 healthy volunteers
Device: MRI scan x 1- Healthy volunteer
For objective 1 (protocol optimization), healthy volunteers undergo imaging using an investigational low SAR CMR scanner for up to two hours, some without- and some with administration of intravenous gadolinium based contrast agents (GBCAs).

Device: MRI scan x 2- Healthy volunteer
For objective 2 (comparative scanning of normals), healthy volunteers undergo two CMR examinations on two different MRI scan-ners (investigational low SAR CMR and conventional 1.5T CMR), some without- and some with administration of intravenous GBCA.

Group B
Group B includes 100 adult subjects of both sexes with known stable cardiovascular disease including adults with stable coronary artery disease after myocardial infarction; adults with heart failure and reduced left ventricular systolic function; adults with pulmonary artery hypertension; adults with congenital heart disease including cardiac shunts; adults with valvular heart disease including aortic stenosis, mitral regurgitation, and tricuspid regurgitation; and adults with metallic cardiovascular implants (such as coronary and peripheral artery stents) known to be safe for CMR at 1.5T.
Device: MRI scan x 2- CAD patients
For objective 3 (comparative scanning of patients), subjects with known stable cardiovascular disease undergo two CMR examinations on two different MRI scanners (investigational low SAR CMR and conventional 1.5T CMR), some without- and some with administration of intravenous GBCA.

Group C
Group C includes 100 adult subjects of both sexes with known non-cardiovascular disease
Device: MRI scan x 2- non-CAD patients
For objective 4 (comparative scanning of patients), subjects with known or suspected disease, including neurological, musculoskele-tal disease, abdominal or lung disease, will undergo two MR exami-nations on two different MRI scanners (investigational low SAR CMR and conventional MR).




Primary Outcome Measures :
  1. Technical feasibility and Non-inferiority of the above measurements and examinations obtained using low SAR CMR versus commercial CMR in healthy volunteers and in patients with heart disease [ Time Frame: 18 months ]
    To determine whether the the low SAR CRM is a feasible alternative to standard CMR


Secondary Outcome Measures :
  1. Numerous exploratory secondary endpoints are sought around the listed measurements across MRI systems and disease states [ Time Frame: 18 months ]


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
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:
  • Men and women age greater than or equal to 8 years
  • Currently healthy
  • Able to provide informed consent in writing
  • Willingness to cooperate with all study procedures (including food restriction) and available for scheduled study events

EXCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:

  • Important past medical illness
  • Conditions that are thought to make MRI unsafe (that will be determined by filling out a separate form) including:

    • Cardiac pacemaker or implantable defibrillator unless it is labeled safe for MRI
    • Cerebral aneurysm clip unless it is labeled safe for MRI
    • Neural stimulator (e.g. TENS-Unit) unless it is labeled safe for MRI
    • Any type of ear implant unless it is labeled safe for MRI
    • Ocular foreign body (e.g. metal shavings)
    • Metal shrapnel or bullet
    • Any implanted device (e.g. insulin pump, drug infusion device), unless it is labeled safe for MRI
  • When gadolinium based contrast agent (GBCA) exposure is planned

    • No gadolinium based contrast agent exposure is permitted if eGFR < 60 mL/min/1.73m^2 using the CKD-EPI equation or equivalent and a serum creatinine measured within 2 weeks without intercurrent change in medical condition or medications.
    • Subjects meeting this exclusion criterion, or without eGFR determination, may still be included in the study but may not be exposed to gadolinium-based contrast agents
  • Pregnancy. When uncertain, subjects will undergo serum pregnancy testing. Results from up to 7 days prior to the examiation will be used. Post-menopausal and surgically sterilized subjects are exempt from this testing.
  • Breast feeding (unless subject is willing to discard breast milk for 24 hours)
  • Healthy volunteers may undergo up to three paired CMR examinations, but they may not receive more than one pair of examinations involving gadolinium-based contrast agents (GBCA)

INCLUSION CRITERIA FOR ADULTS WITH HEART DISEASE:

  • Men and women age greater than or equal to 18 years
  • Able to provide informed consent in writing
  • Willingness to cooperate with all study procedures (including food restriction) and available for scheduled study events
  • Having known heart disease including but not limited to

    • Stable angina pectoris due to epicardial coronary artery obstruction
    • Past myocardial infarction
    • Heart failure with reduced ejection fraction
    • Valvular heart disease
    • Pulmonary artery hypertension
    • Congenital heart disease with or without prior repair
    • Myocarditis
    • Infiltrative cardiomyopathy
    • Hypertrophic cardiomyopathy

EXCLUSION CRITERIA FOR ADULTS WITH HEART DISEASE:

  • Unstable angina, acute coronary syndrome, or myocardial infarction not attributable to PCI, within 2 weeks unless after coronary revascularization of the culprit lesion.
  • Any hemodynamic instability or decompensated heart failure as determined by the enrolling physician.
  • Conditions that are thought to make MRI unsafe (that will be determined by filling out a separate form) including:

    • Certain cardiac implanted electronic devices (CIED) such as cardiac pacemaker or implantable defibrillator
    • Cerebral aneurysm clip unless it is labeled safe for MRI
    • Neural stimulator (e.g. TENS-Unit) unless it is labeled safe for MRI
    • Any type of ear implant unless it is labeled safe for MRI
    • Ocular foreign body (e.g. metal shavings)
    • Metal shrapnel or bullet
    • Any implanted device (e.g. insulin pump, drug infusion device), unless it is labeled safe for MRI
  • Pregnancy. When uncertain, subjects will undergo serum pregnancy testing. Results from up to 7 days prior to the examination will be used. Post-menopausal and surgically sterilized subjects are exempt from this testing.
  • Breast feeding (unless subject is willing to discard breast milk for 24 hours
  • When gadolinium based contrast agent (GBCA) exposure is planned:

    --No gadolinium based contrast agent exposure is permitted if eGFR < 30 mL/min/1.73m^2 using the CKD-EPI equation or equivalent and a serum creatinine measured within 2 weeks without intercurrent change in medical condition or medications.

  • Subjects meeting this exclusion criterion, or without eGFR determination, may still be included in the study but may not be exposed to gadolinium-based contrast agents
  • Patients with asthma or chronic obstructive pulmonary disease are (ineligible for vasodilator stress CMR)
  • Patients with advanced heart block on baseline ECG are (ineligible for vasodilator stress CMR)

EXCLUSION CRITERIA FOR ADULTS WITH CARDIAC IMPLANTED ELECTRONIC DEVICES (CIED, PACEMAKERS OR DEFIBRILLATORS):

  • Low-SAR MRI: Subjects with CIED are not excluded, based on the intrinsic safety of low-SAR MRI.
  • Conventional MRI

    • In order to undergo conventional MRI, subjects with CIEDs must have CIEDs that are labeled as MRI conditional or MRI safe and that are not implanted < 4 weeks prior to MRI exam.
    • Subjects with CIED are excluded from conventional MRI unless they have CIEDs that are labeled as MRI conditional or MRI safe, and that are implanted >= 4 weeks prior to MRI

INCLUSION CRITERIA FOR ADULTS WITH NON-CARDIAC DISEASE:

  • Men and women age >= 18 years
  • Able to provide informed consent in writing
  • Willingness to cooperate with all study procedures (including food restriction) and available for scheduled study events
  • Having known brain disease including but not limited to

    • Transient ischemic attack or stroke after 24 hours of onset
    • Infection, inflammation meningitis
    • Cognitive decline, neurodegenerative disorders
    • Demyelinating disease, multiple sclerosis
    • Loss of consciousness, seizures, epilepsy
    • Brain tumor, metastases, abscess, lesion
    • Vascular pathology
    • Headache
    • Hemorrhage
    • Trauma
  • Have known musculoskeletal disease including but not limited to:

    • Persistent neck pain or radiculopathy
    • Cancer or tumors of the spine
    • Congenital abnormalities of the spinal cord or knee
    • Multiple sclerosis
    • Injury or trauma
    • Fracture evaluation
    • Infectious or inflammatory processes
    • Soft tissue damage
    • Muscle or tendon disorders
    • Knee meniscal disorders
    • Marrow abnormalities
    • Mechanical knee symptoms
    • Vascular conditions
  • Have known abdominal diseases including but not limited to:

    • Bowel obstruction
    • Masses and tumors
    • Crohns disease
    • Diffuse liver disease such as hemochromatosis, hemosiderosis, fatty infiltration
    • Focal hepatic lesions
    • Cirrhotic liver
    • Iron content determination
    • Cystic kidney disease
    • Vascular abnormalities
  • Have known lung disease including but not limited to:

    • Cancer, tumors and masses
    • Vascular and lymphatic abnormalities
    • Pulmonary thromboembolic disease
    • Trauma
    • Suspected bronchiolitis
    • Bronchiectasis or pneumonitis
    • Asthma and other obstructive lung diseases

Pulmonary lymphangioleiomyomatosis

--Cystic and interstitial lung diseases such as pulmonary lymphangioleiomyomatosis and cystic fibrosis

- Have other known non-cardiovascular disease

EXCLUSION CRITERIA FOR ADULTS WITH DISEASE:

  • Acute illness for which investigational imaging might delay care (such as acute stroke before treatment), as determined by the enrolling physician
  • Any hemodynamic instability as determined by the enrolling physician.
  • Conditions that are thought to make MRI unsafe (that will be determined by filling out a separate form) including:

    • Cardiac pacemaker or implantable defibrillator unless it is labeled MRI conditional or MRI safe
    • Cerebral aneurysm clip unless it is labeled safe for MRI
    • Neural stimulator (e.g. TENS-Unit) unless it is labeled safe for MRI
    • Any type of ear implant unless it is labeled safe for MRI
    • Ocular foreign body (e.g. metal shavings)
    • Metal shrapnel or bullet
    • Any implanted device (e.g. insulin pump, drug infusion device), unless it is labeled safe for MRI
  • Pregnancy. When uncertain, subjects will undergo serum pregnancy testing. Results from up to 7 days prior to the examination will be used. Post-menopausal and surgically sterilized subjects are exempt from this testing.
  • Breast feeding in those subjects receiving contrast (unless subject is willing to discard breast milk for 24 hours)
  • - When gadolinium based contrast agent (GBCA) exposure is planned

    • No gadolinium based contrast agent exposure is permitted if eGFR < 30 mL/min/1.73m using the CKD-EPI equation or equivalent and a serum creatinine measured within 2 weeks without intercurrent change in medical condition or medications.
    • Subjects meeting this exclusion criterion, or without eGFR determination, may still be included in the study but may not be exposed to gadolinium-based contrast agents

EXCLUSION CRITERIA FOR OXYGEN INHALTION:

  • Severe chronic obstructive pulmonary disease defined as requiring more than one bronchodilator medication every day or oxygen requiring
  • Prior treatment with bleomycin

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): NCT03331380


Contacts
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Contact: Annette Stine, R.N. (301) 402-5558 stinea@nhlbi.nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Adrienne E Campbell, Ph.D. National Heart, Lung, and Blood Institute (NHLBI)

Additional Information:
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Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT03331380     History of Changes
Other Study ID Numbers: 180011
18-H-0011
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 13, 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ):
1.5 T CMR
Low SAR CMR
Gadolinium
Regadenoson
Adenosine