RECRUITING

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

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Conditions

CAD1.5 T CMRLow SAR CMRGadoliniumRegadenosonAdenosine

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Background: Researchers are testing version of a system known as a magnetic resonance imagining (MRI) scanner that uses strong magnetic fields, radio waves and the like to create images of the organs in the body. 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 a new MRI scanner and software changes to create better pictures. Eligibility: People with disease and healthy volunteers, ages 18 and older. Design: Participants will be screened with blood tests. Participants may have both the new MRI and a conventional MRI 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. 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

Official Title

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

Quick Facts

Study Start:2018-01-05
Study Completion:2026-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03331380

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Men and women age greater than or equal to 18 years
  2. * Able to provide informed consent in writing
  3. * Willingness to cooperate with all study procedures (including food restriction) and available for scheduled study events
  4. * Subjects having known heart disease including but not limited to
  5. * Stable angina pectoris due to epicardial coronary artery obstruction
  6. * Past myocardial infarction
  7. * Heart failure with reduced ejection fraction
  8. * Valvular heart disease
  9. * Pulmonary artery hypertension
  10. * Congenital heart disease with or without prior repair
  11. * Myocarditis
  12. * Infiltrative cardiomyopathy
  13. * Hypertrophic cardiomyopathy
  14. * Having known brain disease including but not limited to:
  15. * Transient ischemic attack or stroke after 24 hours of onset
  16. * Infection, inflammation meningitis
  17. * Cognitive decline, neurodegenerative disorders
  18. * Demyelinating disease, multiple sclerosis
  19. * Loss of consciousness, seizures, epilepsy
  20. * Brain tumor, metastases, abscess, lesion
  21. * Vascular pathology
  22. * Headache
  23. * Hemorrhage
  24. * Trauma
  25. * Have known musculoskeletal disease including but not limited to:
  26. * Persistent neck pain or radiculopathy
  27. * Cancer or tumors of the spine
  28. * Congenital abnormalities of the spinal cord or knee
  29. * Multiple sclerosis
  30. * Injury or trauma
  31. * Fracture evaluation
  32. * Infectious or inflammatory processes
  33. * Soft tissue damage
  34. * Muscle or tendon disorders
  35. * Knee meniscal disorders
  36. * Marrow abnormalities
  37. * Mechanical knee symptoms
  38. * Vascular conditions
  39. * Have known abdominal diseases including but not limited to:
  40. * Bowel obstruction
  41. * Masses and tumors
  42. * Crohns disease
  43. * Diffuse liver disease such as hemochromatosis, hemosiderosis, fatty infiltration
  44. * Focal hepatic lesions
  45. * Cirrhotic liver
  46. * Iron content determination
  47. * Cystic kidney disease
  48. * Vascular abnormalities
  49. * Have known lung disease including but not limited to:
  50. * Cancer, tumors and masses
  51. * Vascular and lymphatic abnormalities
  52. * Pulmonary thromboembolic disease
  53. * Trauma
  54. * Suspected bronchiolitis
  55. * Bronchiectasis or pneumonitis
  56. * Asthma and other obstructive lung diseases
  57. * Pulmonary lymphangioleiomyomatosis
  58. * Cystic and interstitial lung diseases such as pulmonary lymphangioleiomyomatosis and cystic fibrosis
  59. * Have other known non-cardiovascular disease
  1. * Conditions that are thought to make MRI unsafe (that will be determined by filling out a separate form) including:
  2. * Cerebral aneurysm clip unless it is labeled safe for MRI
  3. * Neural stimulator (e.g. TENS-Unit) unless it is labeled safe for MRI
  4. * Any type of ear implant unless it is labeled safe for MRI
  5. * Ocular foreign body (e.g. metal shavings)
  6. * Metal shrapnel or bullet
  7. * Any implanted device (e.g. insulin pump, drug infusion device), unless it is labeled safe for MRI
  8. * Pregnancy. When uncertain, subjects will undergo either urine or serum pregnancy testing. Results from up to 3 days prior to the examination will be used. Post-menopausal and surgically sterilized subjects are exempt from this testing.
  9. * If a urine or serum pregnancy test was administered as part of a referral protocol, and the test was administered up to 3 days prior to MRI examination for this protocol, a new pregnancy test will not be required for this protocol.
  10. * If a pregnancy test has not been administered within 3 days of MRI examination for this protocol, a serum or urine pregnancy test will be administered. Medical personnel will determine which pregnancy test is appropriate based on subject s medical history, screening, and individual scenario. In addition, the subject will be asked if she may be pregnant prior to the performance of the MRI, even if the pregnancy test was negative within the past week. The pregnancy test will be repeated if she answers in the affirmative.
  11. * Objective 1 and 2, Healthy Volunteers: 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.
  12. * Objective 3 and 4, Volunteers with Cardiac and Non-Cardiac Disease: No gadolinium based contrast agent exposure is permitted if eGFR \< 30 mL/min/1.73m\^(2) using the CKDEPI equation \[25\] or equivalent and a serum creatinine measured within 2 weeks without
  13. * 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
  14. * Breast feeding (unless subject is willing to discard breast milk for 24 hours)
  15. * Does not wish to be exposed to gadolinium.
  16. * Severe chronic obstructive pulmonary disease defined as requiring more than one bronchodilator medication every day or continuous oxygen requiring
  17. * Prior treatment with bleomycin
  18. * A history of allergic reaction to any intravenous iron product
  19. * Allergy to ferumoxytol or to mannitol excipient
  20. * Breast feeding
  21. * Does not wish to be exposed to ferumoxytol
  22. * Iron overload
  23. * A history of reaction to oral contrast (if using barium sulfate)
  24. * Breast feeding unless subject is willing to discard breast milk for 24 hours (if using barium sulfate)
  25. * Allergy to pineapple (if using pineapple juice)
  26. * Does not wish to be exposed to oral contrast
  27. * Unstable angina, acute coronary syndrome, or myocardial infarction not attributable to PCI, within 2 weeks unless after coronary revascularization of the culprit lesion.
  28. * Any hemodynamic instability or decompensated heart failure as determined by the enrolling physician.
  29. * Adenosine: Patients with asthma or chronic obstructive pulmonary disease of any severity are ineligible for vasodilator stress CMR with adenosine.
  30. * Regadenoson: Only patients with severe or uncontrolled asthma or severe or uncontrolled chronic obstructive pulmonary disease are ineligible for vasodilator stress CMR with regadenoson. This will be determined at the discretion of the supervising provider based on medical records and physical exam.
  31. * Patients with advanced heart block on baseline ECG are ineligible for vasodilator stress CMR
  32. * Acute illness for which investigational imaging might delay care (such as acute stroke before treatment), as determined by the enrolling physician
  33. * Any hemodynamic instability as determined by the enrolling physician.
  34. * Subjects with MRI-conditional and legacy CIEDs are not excluded, based on the intrinsic safety of low-SAR MRI.
  35. * Subjects with CIEDs are excluded if they have pacemakers implanted before 1998; ICDs implanted before 2000; temporary, epicardial or abandoned leads; and CIEDs implanted \<4 weeks prior to MRI exam.

Contacts and Locations

Study Contact

Anastasia Tsakirellis, C.R.N.P.
CONTACT
(301) 921-6986
anastasia.tsakirellis@nih.gov
Adrienne E Campbell, Ph.D.
CONTACT
(301) 480-4080
adrienne.campbell@nih.gov

Principal Investigator

Adrienne E Campbell, Ph.D.
PRINCIPAL_INVESTIGATOR
National Heart, Lung, and Blood Institute (NHLBI)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

  • Adrienne E Campbell, Ph.D., PRINCIPAL_INVESTIGATOR, National Heart, Lung, and Blood Institute (NHLBI)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-01-05
Study Completion Date2026-05-31

Study Record Updates

Study Start Date2018-01-05
Study Completion Date2026-05-31

Terms related to this study

Keywords Provided by Researchers

  • 1.5 T CMR
  • Low SAR CMR
  • Gadolinium
  • Regadenoson
  • Adenosine

Additional Relevant MeSH Terms

  • CAD