Your session is about to expire
← Back to Search
Low SAR MRI Scans for Coronary Heart Disease
N/A
Recruiting
Led By Adrienne E Campbell, Ph.D.
Research Sponsored by National Heart, Lung, and Blood Institute (NHLBI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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 (for Subjects with Heart Disease)
Subjects with 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 (for Subjects with Non-Cardiac Disease)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 months
Awards & highlights
Study Summary
This trial is testing a new, lower-energy MRI scanner to see if it creates better pictures than a conventional MRI. The trial is for people with disease and healthy volunteers, ages 18 and older.
Who is the study for?
This trial is for adults aged 18 and older, both with coronary heart disease and healthy volunteers. Participants must be willing to follow study procedures, including food restrictions, and provide written consent. Those with allergies to certain contrast agents or severe medical conditions making MRI unsafe are excluded.Check my eligibility
What is being tested?
Researchers are testing a new low-energy MRI scanner system that could be safer for patients with metal implants. The study involves comparing images from the new scanner against conventional MRIs, possibly using a dye or drug to enhance image quality.See study design
What are the potential side effects?
Potential side effects may include temporary chest pain or shortness of breath from vasodilator drugs used during scans. Allergic reactions to dyes like gadolinium might occur, although rare.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a known heart condition.
Select...
I do not have any known brain conditions or injuries.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 72 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Technical feasibility and Non-inferiority of the above measurements and examinations ob-tained using low SAR CMR versus commercial CMR in healthy volun-teers and in patients with heart disease
Secondary outcome measures
Numerous exploratory secondary endpoints are sought around the listed measurements across MRI systems and disease states
Trial Design
3Treatment groups
Experimental Treatment
Group I: Group CExperimental Treatment1 Intervention
Group C includes 500 adult subjects of both sexes with known non-cardiovascular disease
Group II: Group BExperimental Treatment1 Intervention
Group B includes 500 adult subjects of both sexes with known sta-ble 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
Group III: Group AExperimental Treatment2 Interventions
Group A includes 600 healthy adult volunteers of both sexes with-out known cardiovascular disease
Find a Location
Who is running the clinical trial?
National Heart, Lung, and Blood Institute (NHLBI)Lead Sponsor
3,837 Previous Clinical Trials
47,848,777 Total Patients Enrolled
Adrienne E Campbell, Ph.D.Principal InvestigatorNational Heart, Lung, and Blood Institute (NHLBI)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not been exposed to a specific contrast agent if my kidney function is below a certain level.I am 18 years old or older.I have a known heart condition.I do not have any known brain conditions or injuries.I do not have recent severe heart issues, uncontrolled asthma, or severe lung problems.I refuse to take medication to open my airways.My heart device is safe for MRI, and it was implanted at least 4 weeks ago.I have had less than three MRI scans with contrast in the last year.I am breastfeeding but can discard milk for 24 hours and avoid gadolinium exposure.I have severe COPD and need multiple medications or constant oxygen.I am not allergic to intravenous iron, ferumoxytol, or mannitol, and I am not breastfeeding or willing to stop for 24 hours.I consider myself currently healthy.I have a known musculoskeletal condition such as persistent neck pain, spinal issues, or knee disorders.I have a known abdominal condition like Crohn's disease or liver issues.I have a known lung condition other than heart-related issues.I use bronchodilators regularly or have had lung function tests with them.
Research Study Groups:
This trial has the following groups:- Group 1: Group B
- Group 2: Group C
- Group 3: Group A
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the greatest number of participants in this research endeavor?
"Affirmative. According to data posted on clinicaltrials.gov, the trial is actively recruiting patients who meet its inclusion criteria. This medical study was inaugurated on May 1st 2018 and has since been updated as recently as November 19th 2022; 2100 individuals are needed from one site for successful completion of this trial."
Answered by AI
Is the research team currently enlisting participants for this experiment?
"Confirmed. According to the information provided on clinicaltrials.gov, this trial is currently in the process of seeking out potential candidates. It was first posted on May 1st 2018 and has been recently updated as of November 19th 2022; it is looking for 2100 participants across one single location."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger