NCT00027170

Technical Development of Cardiovascular Magnetic Resonance Imaging

Completed Last updated 30 March 2021

What this trial tests

trial testing Siemens MRI scanner in Cardiomyopathy in 8,781 participants. Completed in 19 November 2020.

Timeline

26 November 2001

Primary endpoint
5 April 2018

19 November 2020

Quick facts

Lead sponsor	National Heart, Lung, and Blood Institute (NHLBI)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	8,781
Start date	26 November 2001
Primary completion	5 April 2018
Estimated completion	19 November 2020
Sites	2 locations across United States

Drugs / interventions tested

• Siemens MRI scanner

Conditions studied

• Cardiomyopathy — all drugs for Cardiomyopathy →
• Congenital Heart Disease — all drugs for Congenital Heart Disease →
• Cardiovascular Disease — all drugs for Cardiovascular Disease →
• Cardiac Magnetic Resonance Imaging — all drugs for Cardiac Magnetic Resonance Imaging →

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Who can join

Adults 18 to 100, any sex, with Cardiomyopathy or Congenital Heart Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will explore new ways of using magnetic resonance imaging (MRI) to evaluate the heart and blood vessels of patients with cardiovascular disease, including better detection of myocardial infarction (heart attack) and blockage of heart and leg arteries.

Patients 18 years of age and older with cardiovascular disease may be eligible for this study.

All participants will have magnetic resonance imaging of the heart. MRI uses a magnetic field and radio waves to show structural and chemical changes in tissues. For the procedure, the patient lies on a table surrounded by a metal cylinder (the scanner). A 'gadolinium contrast' material may be injected into the patient s vein during part of the study to brighten the images. Patients wear earplugs during the scan to muffle loud knocking sounds caused by the electrical switching of the magnetic fields. They will be asked to hold their breath intermittently for 5 to 20 seconds during the scan. They will be monitored with an electrocardiogram (EKG) during the procedure and will be in contact by intercom at all times with the person performing the scan. Patients can request to stop the study and come out of the scanner at any time. The procedure may last from 30 to 90 minutes. An echocardiogram a test that uses sound waves to produce pictures of the heart and blood vessels-may be done to confirm the MRI findings. In addition, patients may undergo one or more of the following optional studies:

* Dobutamine stress MRI - This test uses dobutamine-a medicine that simulates exercise by increasing heart rate and heart function-to detect blockages in the coronary arteries (vessels that supply oxygen and nutrients to the heart) and locate areas of the heart that are permanently damaged, perhaps by a previous heart attack. For this test, MRI pictures of the heart are taken before, during and after administration of dobutamine. Gadolinium may be injected during part of the study to brighten the images. An EKG will be used to monitor the heart during the procedure.
* Vasodilator MRI - The procedure and objectives of this test are the same as those described for dobutamine stress MRI, except that this study uses dipyridamole or adenosine. These drugs dilate blood vessels, causing increased blood flow to the heart.
* Plethysmography MRI - This test determines the presence and severity of narrowing in arteries that supply blood to the leg. Blockage of these vessels often causes pain while walking. This study will compare plethysmography MRI with venous occlusion plethysmography, an older method of measuring blood flow in the legs. For venous occlusion plethysmography, a large blood pressure cuff is placed around the upper leg and a strain gauge (thin elastic band) is placed around the calf. The pressure cuff is inflated very tightly for 5 minutes to block blood flow to the leg, and another pressure cuff over the ankle is also inflated. When the large cuff is deflated, blood rushes to the leg, a smaller cuff is inflated to a low pressure, and the strain gauge measures the maximum blood flow to the leg for 1 or 2 more minutes. This procedure is done once or twice outside the MRI scanner and once or twice inside the scanner. The scans are performed as described above for the dobutamine and vasodilator studies. The strain gauge is not used for plethysmography MRI the MRI pictures are used to measure flow.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Diagnostic Performance of Fully Automated Pixel-Wise Quantitative Myocardial Perfusion Imaging by Cardiovascular Magnetic Resonance.
   Hsu LY, Jacobs M, Benovoy M, Ta AD, et al · · 2018 · cited 113× · PMID 29454767 · DOI 10.1016/j.jcmg.2018.01.005
2. Evaluation of an automated method for arterial input function detection for first-pass myocardial perfusion cardiovascular magnetic resonance.
   Jacobs M, Benovoy M, Chang LC, Arai AE, et al · · 2016 · cited 34× · PMID 27055445 · DOI 10.1186/s12968-016-0239-0
3. Mechanisms for overestimating acute myocardial infarct size with gadolinium-enhanced cardiovascular magnetic resonance imaging in humans: a quantitative and kinetic study.
   Hammer-Hansen S, Bandettini WP, Hsu LY, Leung SW, et al · · 2016 · cited 26× · PMID 25983233 · DOI 10.1093/ehjci/jev123
4. Fully quantitative pixel-wise analysis of cardiovascular magnetic resonance perfusion improves discrimination of dark rim artifact from perfusion defects associated with epicardial coronary stenosis.
   Ta AD, Hsu LY, Conn HM, Winkler S, et al · · 2018 · cited 17× · PMID 29514708 · DOI 10.1186/s12968-018-0436-0
5. Automated Segmental Analysis of Fully Quantitative Myocardial Blood Flow Maps by First-Pass Perfusion Cardiovascular Magnetic Resonance.
   Jacobs M, Benovoy M, Chang LC, Corcoran D, et al · · 2021 · cited 16× · PMID 33996344 · DOI 10.1109/access.2021.3070320
6. FLASH proton density imaging for improved surface coil intensity correction in quantitative and semi-quantitative SSFP perfusion cardiovascular magnetic resonance.
   Nielles-Vallespin S, Kellman P, Hsu LY, Arai AE. · · 2015 · cited 9× · PMID 25827180 · DOI 10.1186/s12968-015-0120-6
7. CMR provides comparable measurements of diastolic function as echocardiography.
   Fujikura K, Sathya B, Acharya T, Benovoy M, et al · · 2024 · cited 7× · PMID 38778036 · DOI 10.1038/s41598-024-61992-6
8. Framingham Risk Score Is an Ineffective Screening Strategy for Coronary Heart Disease in Long-Term Allogeneic Hematopoietic Cell Transplant Survivors.
   Jain NA, Chen MY, Shanbhag S, Anandi P, et al · · 2020 · cited 5× · PMID 34595451 · DOI 10.2991/chi.d.200508.001