Bethesda, MDNCT03331380Now EnrollingIRB Ready

CAD Clinical Trial in Bethesda, MD

Access cutting-edge cad treatment through this clinical trial at a research site in Bethesda. Study-provided care at no cost to qualified participants.

Sponsored by National Heart, Lung, and Blood Institute (NHLBI)

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Expert Care in Bethesda

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IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related cad treatment provided free

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Why Participate?

  • No-Cost Study Care

  • Local to Bethesda

    Convenient for MD residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Bethesda site if eligible
  4. 4Begin participation

About This CAD Study in Bethesda

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

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

Who Can Participate

Inclusion Criteria

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 Inclusion Criteria for Healthy Volunteers (Objectives 1 and 2) -Currently healthy, self-reported Inclusion Criteria for Subjects with Heart Disease (Objective 3)
Subjects 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 Inclusion Criteria for Subjects with Non-Cardiac Disease (Objective 4)
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
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
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 Inclusion criteria for bronchodilators: \- Only subjects who use bronchodilators routinely or those have undergone previous pulmonary function testing with bronchodilators will be invited to undergo bronchodilator testing during MRI.

Exclusion Criteria

Conditions that are thought to make MRI unsafe (that will be determined by filling out a separate form) including:
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 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.
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.
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. Exclusion Criteria for Gadolinium: -When gadolinium based contrast agent (GBCA) exposure is planned
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.
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 intercurrent change in medical condition or medications. --For all objectives not more than two research MRI exams with GBCA exposure in a 12 month period. Research MRI exams performed outside of this protocol will be included in the 12 month period.
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
Breast feeding (unless subject is willing to discard breast milk for 24 hours)
Does not wish to be exposed to gadolinium. Exclusion Criteria for Oxygen Inhalation:
Severe chronic obstructive pulmonary disease defined as requiring more than one bronchodilator medication every day or continuous oxygen requiring
Prior treatment with bleomycin Exclusion Criteria for Ferumoxytol Contrast
A history of allergic reaction to any intravenous iron product
Allergy to ferumoxytol or to mannitol excipient
Breast feeding
Does not wish to be exposed to ferumoxytol
Iron overload Exclusion Criteria for oral contrast agent:
A history of reaction to oral contrast (if using barium sulfate)
Breast feeding unless subject is willing to discard breast milk for 24 hours (if using barium sulfate)
Allergy to pineapple (if using pineapple juice)
Does not wish to be exposed to oral contrast Exclusion Criteria for Healthy Volunteers (Objectives 1 and 2) -Important past medical illness Exclusion Criteria for Adults with heart Disease (Objective 3)
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.
Adenosine: Patients with asthma or chronic obstructive pulmonary disease of any severity are ineligible for vasodilator stress CMR with adenosine.
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.
Patients with advanced heart block on baseline ECG are ineligible for vasodilator stress CMR Exclusion Criteria for Adults with Non-Cardiac Disease (Objective 4)
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. Exclusion criteria for bronchodilators: \- Patient refuses bronchodilator administration. Exclusion criteria for adults with cardiac implanted electronic devices (CIED, pacemakers or defibrillators: Low-SAR MRI:
Subjects with MRI-conditional and legacy CIEDs are not excluded, based on the intrinsic safety of low-SAR MRI.
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. Conventional MRI: -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 greater than or equal to 4 weeks prior to MRI.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Bethesda?

Yes, this clinical trial (NCT03331380) has an active research site in Bethesda, MD that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

CAD Treatment Options in Bethesda, MD

If you're searching for cad treatment options in Bethesda, MD, this clinical trial (NCT03331380) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Bethesda research site is actively enrolling participants for this clinical trial. You'll receive care from experienced cad specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all cad clinical trials near you to find additional studies recruiting in your area.

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