Technical Development of Cardiovascular Magnetic Resonance Imaging
Technical Development of Cardiovascular MRI
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 100 Years
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 5 years
- Procedures mentioned: MRI scans, Blood draws, Physical exams, Heart tracing (ECG), Questionnaires
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Objective: To develop and test new methods for imaging the heart and blood vessels using MRI."
- "Eligibility: People ages 18 years and older who are having an MRI of their heart or blood vessels."
- "Participants will have a physical exam and blood tests."
- "They will have an electrocardiogram (ECG) to measure the heart s electrical activity."
- "Then they will have their scheduled MRI scan."
- "The MRI scanner is a large, hollow tube."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests new MRI methods to take pictures of the heart and blood vessels. It is for adults who need a heart or blood vessel MRI, and for healthy adult volunteers.
Background: In the U.S., over 6.5 million people have heart failure. Researchers want to develop new testing methods for cardiovascular problems using magnetic resonance imaging (MRI) to improve the clinical diagnosis and management of people with heart failure. Objective: To develop and test new methods for imaging the heart and blood vessels using MRI. Eligibility: People ages 18 years and older who are having an MRI of their heart or blood vessels. Healthy volunteers are also needed. Design: Participants will be screened with a medical history. Participants will have a physical exam and blood tests. They will have an electrocardiogram (ECG) to measure the heart s electrical activity. Then they will have their scheduled MRI scan. The MRI scanner is a large, hollow tube. Participants will lie on a table that moves in and out of the tube. During the MRI, they may have contrast dye injected through an intravenous line inserted into their arm or hand. ECG may be used to monitor their heartbeat or coordinate pictures with their heartbeat. A flexible belt may be used to monitor their breathing. A finger probe may be used to track their heart rate and/or oxygenation level. Their blood pressure may be measured. Pictures may be taken of their blood vessels, heart, and lungs before, during, and after they get medicine to increase blood flow. They may lie flat and pedal a stress bicycle to increase their heart rate. Participation will last for 5 years. During that time, participants may receive a yearly survey about their health. They may be contacted for an optional follow-up MRI within 2 years of their MRI.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older.
- Sign and date a form agreeing to join the study.
- Be willing to follow study steps and be available for the study.
- Either need an MRI for medical care or join as a healthy volunteer.
Who can't join
- Have an implanted device or metal in your body that has not been cleared as safe for MRI.
- Be pregnant.
- For gadolinium contrast dye: have very poor kidney function or a known allergy to this dye. You may still qualify for an MRI without dye or with ferumoxytol dye.
- For gadolinium contrast dye: be breastfeeding and unwilling to throw away breast milk for 24 hours after getting the dye.
- For ferumoxytol contrast dye: have a known allergy to ferumoxytol or its ingredient mannitol.
- For stress tests using adenosine or regadenoson: have certain lung or heart rhythm problems, very low or uncontrolled high blood pressure, an allergy to these drugs, or dipyridamole use within 48 hours.
- For medicine-based stress tests: have new or worsening heart-related chest pain, a sudden heart blood-flow problem, or a heart attack within the past 2–4 days. Seizure disorders also rule out regadenoson.
- For healthy volunteers used to set normal test values: have a major illness, heart-related chest pain, shortness of breath, currently smoke, or have trouble making decisions. Major illnesses include high blood pressure needing medicine, diabetes, inherited high cholesterol, and heart or blood vessel disease.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
* INCLUSION CRITERIA: Group A: In order to be eligible to participate in this study, an individual must meet all of the following criteria: * Provision of signed and dated informed consent form by subject * Stated willingness to comply with all study procedures and availability for the duration of the study * Male or female, 18 years or older * Subjects undergoing a clinically indicated MRI examination. Examples of medical indications include known or suspected heart failure or cardiomyopathy, chest pain with known or suspected coronary artery disease, unexplained dyspnea, valve disease, known or suspected congenital heart disease, cardiac masses and known or suspected aortic disease, exposure to cardiotoxic drugs, and systemic illnesses with known associated cardiovascular involvement. Group B, Healthy volunteers enrolled for developmental testing and establishing reference values for the custom pulse sequences. In order to be eligible to participate in this study, an individual must meet all of the following criteria: * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * Male or female, 18 years or older EXCLUSION CRITERIA: 1. An individual who meets any of the following criteria will be excluded from participation in this study: * Unable to undergo magnetic resonance imaging because of: * Central nervous system aneurysm clips * Implanted neural stimulator * Implanted cardiac pacemaker or defibrillator * Cochlear implant * Ocular foreign body (e.g. metal shavings) * Implanted Insulin pump * Metal shrapnel or bullet unless any of the above objects have been cleared as safe for MRI according to the assessment present as clinical routine at the site. * 2.For examinations that include contrast injection of GBCA: \-- renal excretory dysfunction, estimated glomerular filtration rate \<= 30 mL/min/1.73m(2) body surface area.(estimated glomerular filtration rate is only determined according to the institutional guidelines of patients at risk of renal dysfunction and may also depend upon the dose of GBCA administered). \-- Known allergic reactions to GBCA \-- Subjects may still be invited for non-contrast enhanced examinations or undergo MR examination with ferumoxytol as contrast agent. . For examinations that include contrast injection of ferumoxytol \-- Known allergic reactions to ferumoxytol or to mannitol excipient * For subjects with a planned pharmacological stress test with adenosine or regadenoson the following contraindications will be considered as exclusion criteria: --Bronchospastic lung disease with ongoing wheezing or history of significant reactive airway disease --Second- or third- degree atrioventricular blood, sinus node disease without a functioning MR conditional pacemaker --Systolic blood pressure \< 90 mmHg --Uncontrolled hypertension (systolic BP \> 200 mmHg or diastolic BP \> 110 mmHg) --Recent (\< 48hr) use of dipyridamole of dipyridamole- containing medications --Known hypersensitivity to adenosine or regadenoson. * Unstable angina, acute coronary syndrome, or less than 2- 4 days after an acute myocardial infarction * For regadenoson only: seizure disorder as regadenoson may lower seizure threshold. Aminophylline should not be used in cases of seizures associated with Regadenoson. * Pregnant Women. * Lactating Women for administration of GBCA unless the subjects is willing to discard the milk for 24 hours after receiving gadolinium In addition, the following exclusion criteria pertains to Group B, healthy volunteers to be considered for reference values: * Known history of major illness, including, but not limited to having a hypertension diagnosis in need of anti-hypertensive medication, myocardial infarction, diabetes, familial hypercholesterolemia, cardiomyopathy, congenital heart disease, moderate or severe valvular disease, cerebrovascular insult or peripheral vascular disease, symptoms of angina or dyspnea, current smoker. * Decisionally impaired individuals
Study sites (2)
DC
- Medstar Washington Hospital Center · Washington D.C., DC 20010James H. Boscoe, MA, CIP · Study contact · 301-560-2912 · MHRI-ORIHelpDesk@medstar.netMore trials in Washington D.C.
MD
- National Institutes of Health Clinical Center · Bethesda, MD 20892For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) · Study contact · 800-411-1222 ext. TTY8664111010 · prpl@cc.nih.govMore trials in Bethesda