Noninvasive Imaging of Heart Failure: A Pilot Study
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|ClinicalTrials.gov Identifier: NCT01160471|
Recruitment Status : Completed
First Posted : July 12, 2010
Last Update Posted : November 30, 2018
|First Submitted Date||July 9, 2010|
|First Posted Date||July 12, 2010|
|Last Update Posted Date||November 30, 2018|
|Study Start Date||July 1, 2010|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures
||Post contrast myocardial T1 measured by CMR. [ Time Frame: Study end ]
The primary aim of this protocol is to investigate noninvasive imaging methods for quantifying diffuse myocardial fibrosis with cardiac magnetic resonance imaging(CMR) in heart failure patient
|Original Primary Outcome Measures||Not Provided|
|Change History||Complete list of historical versions of study NCT01160471 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures||Not Provided|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief Title||Noninvasive Imaging of Heart Failure: A Pilot Study|
|Official Title||Noninvasive Imaging of Heart Failure|
- Heart failure is a common cardiovascular disorder whose incidence increases with age, affecting up to 10% of people older than 65 years of age. As the population ages, the prevalence and cost of heart failure will continue to rise. Researchers are interested in using noninvasive imaging methods to better understand the symptoms and effects of heart failure.
- To conduct a noninvasive comparative imaging study of individuals with heart failure.
- Individuals at least 18 years of age who have been diagnosed with heart failure (with at least mild symptoms and slight limitations on physical activity).
|Detailed Description||More than 9% of American men and close to 5% of women ages 60 to 79 years report a diagnosis of heart failure, where above the age of 80 years these figures increase to 13.8% and 12.2%, respectively. Projection into the middle part of this century suggests that, as the population ages, the prevalence and cost of heart failure will continue to rise. The primary aim of this proposal is to investigate noninvasive imaging methods for quantifying diffuse myocardial fibrosis with cardiac magnetic resonance imaging (CMR) in heart failure patients. The secondary aims are to investigate the association between diffuse fibrosis detected by CMR with left ventricular function, and examine the utility of multi-detector CT (MDCT) in detecting diffusion myocardial fibrosis.|
|Study Design||Observational Model: Case-Control
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Non-Probability Sample|
|Study Population||Heart Failure Subjects: A.Men and Women; age >18 with a clinical diagnosis of heart failure;New York; B.Heart Association functional class II or worse; C.For the normal ejection fraction arm. 1. Preserved left ventricular ejection fraction (EF >50%); 2. Diastolic dysfunction defined one or more of the following; a. LVEDP > 16 mm Hg; @@@b. PCW > 12 mm Hg; c. E/E' ratio >15; d. E/E' ratio >8 AND NT-proBNP >220 pg/mL; For the systolic dysfunction arm. 3.Left ventricular ejection fraction <40%@@@Normal Control: G.Men and women without a clinical diagnosis of heart failure.@@@|
|Publications *||Nacif MS, Liu Y, Yao J, Liu S, Sibley CT, Summers RM, Bluemke DA. 3D left ventricular extracellular volume fraction by low-radiation dose cardiac CT: assessment of interstitial myocardial fibrosis. J Cardiovasc Comput Tomogr. 2013 Jan-Feb;7(1):51-7. doi: 10.1016/j.jcct.2012.10.010. Epub 2012 Dec 4.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Original Estimated Enrollment
|Study Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
The common inclusion criteria between patients and controls are:
A. Able to understand and sign informed consent.
B. Able to complete a MRI or CT scan.
C. Age greater than or equal to 18 years old.
Heart Failure subject:
D. Men and women with a clinical diagnosis of heart failure.
E. New York Heart Association functional class II or worse.
F. For the normal ejection fraction arm.
|Ages||18 Years to 100 Years (Adult, Older Adult)|
|Accepts Healthy Volunteers||No|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||United States|
|Removed Location Countries|
|Other Study ID Numbers||100153
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC)|
|Study Sponsor||National Institutes of Health Clinical Center (CC)|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||November 21, 2018|