Technical Development of Cardiovascular MRI
概览
- 阶段
- 不适用
- 干预措施
- Affected participants
- 疾病 / 适应症
- Cardiovascular Disease
- 发起方
- National Heart, Lung, and Blood Institute (NHLBI)
- 入组人数
- 3400
- 试验地点
- 2
- 主要终点
- To evaluate performance of novel pulse sequences for cardiovascular MRI in patients and healthy volunteers of both genders
- 状态
- 招募中
- 最后更新
- 上个月
概览
简要总结
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.
详细描述
Study Desccription: This protocol allows testing of novel research pulse sequences in investigational cardiovascular magnetic resonance imaging (MRI) and allows application of custom pulse sequences that are not market-cleared in routine clinical MRI. Objectives: To evaluate performance of novel pulse sequences for cardiovascular MRI in patients and healthy volunteers. To provide a regulatory framework (abbreviated IDE) to implement and test custom pulse sequences (a non-significant risk medical device) in patients with cardiovascular disease. Endpoints: Primary Endpoint : Successful clinical performance of pulse sequences measured as the number of subjects with custom and novel pulse sequences that has provided diagnostic quality image. Secondary Endpoint: Reference values in healthy volunteers for measurements of myocardial perfusion, T1, T2, and extracellular volume from custom pulse sequences. Exploratory endpoints: * Differences in perfusion, function, infarction, extracellular volume, T1, T2 and T2\*, flow with heart disease etiology, treatment and functional class of disease as well as age, sex, race and correlations between these parameters. * Relationship with clinical markers such as prognostic influence and change in patient management based on findings from MRI examination including the custom pulse sequences may be explored. * Comparisons to the results from novel and custom sequences to standard product sequences provided by the vendor may be performed. * To investigate the relationship between cardiac MRI biomarkers and blood biomarkers of heart disease in order to understand the disease process and enable a deep phenotyping of heart failure.
研究者
入排标准
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Affected participants
Participants with a clinically indicated referral for cardiac MRI
Healthy participants
Healthy individuals of various ethnicities to serve as reference ranges
结局指标
主要结局
To evaluate performance of novel pulse sequences for cardiovascular MRI in patients and healthy volunteers of both genders
时间窗: 1 day
Clinical performance of pulse sequences measured as the number of subjects with custom and novel pulse sequences that has provided diagnostic quality image
次要结局
- Establishing reference values for measurements from custom sequences.(1 day)