Abstract:
BACKGROUND:Acute allograft rejection is a major cause of early mortality in the first year after heart transplantation in adults. Although endomyocardial biopsy (EMB) is not a perfect "gold standard" for a correct diagnosis of acute allograft rejection, it is considered the best available test and thus, is the current standard practice. Unfortunately, EMB is an invasive and costly procedure that is not without risk. Recent evidence suggests that acute allograft rejection causes delays in ventricular repolarization and thereby increases the cellular action potential duration resulting in a longer QT interval on the electrocardiogram (ECG). No prospective study to date has investigated whether such increases in the QT interval could provide early detection of acute allograft rejection. Therefore, in the Novel Evaluation With Home Electrocardiogram And Remote Transmission (NEW HEART) study, we plan to investigate the potential benefit of daily home QT interval monitoring to predict acute allograft rejection. METHODS/DESIGN:The NEW HEART study is a prospective, double-blind, multi-center descriptive research study. A sample of 325 adult heart transplant recipients will be recruited within six weeks of transplant from three sites in the United States. Subjects will receive the HeartView™ ECG recorder and its companion Internet Transmitter, which will transmit the subject's ECG to a Core Laboratory. Subjects will be instructed to record and transmit an ECG recording daily for 6 months. An increase in the QTC interval from the previous day of at least 25 ms that persists for 3 consecutive days will be considered abnormal. The number and grade of acute allograft rejection episodes, as well as all-cause mortality, will be collected for one year following transplant surgery. DISCUSSION:This study will provide "real world" prospective data to determine the sensitivity and specificity of QTC as an early non invasive marker of cellular rejection in transplant recipients during the first post-transplant year. A non-invasive indicator of early allograft rejection in heart transplant recipients has the potential to limit the number and severity of rejection episodes by reducing the time and cost of rejection surveillance and by shortening the time to recognition of rejection. TRIAL REGISTRATION:ClinicalTrials.gov: NCT01365806.
journal_name
BMC Cardiovasc Disordjournal_title
BMC cardiovascular disordersauthors
Doering LV,Hickey K,Pickham D,Chen B,Drew BJdoi
10.1186/1471-2261-12-14subject
Has Abstractpub_date
2012-03-02 00:00:00pages
14issn
1471-2261pii
1471-2261-12-14journal_volume
12pub_type
临床试验,杂志文章,多中心研究abstract:BACKGROUND:Cardio-metabolic syndrome (CMS) is a highly prevalent condition. There is an urgent need to identify effective and integrated multi-disciplinary approaches that can reduce risk factors for CMS. METHODS:Sixty-two patients with a history of CMS were randomized 1:1 into two groups: a standard information -only...
journal_title:BMC cardiovascular disorders
pub_type: 杂志文章,随机对照试验
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abstract:BACKGROUND:Cardiac rehabilitation (CR) programs provide significant benefit for people with cardiovascular disease. Despite these benefits, such services are not universally available. We designed and evaluated a national home-based CR (HBCR) program in the Veterans Health Administration (VHA). The primary aim of the s...
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pub_type: 杂志文章
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abstract:BACKGROUND:We assessed the degree to which differences in guideline-based medical therapy for acute myocardial infarction (AMI) contribute to the higher mortality associated with kidney disease. METHODS:In the PREMIER registry, we evaluated patients from 19 US centers surviving AMI. Cox regression evaluated the associ...
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pub_type: 杂志文章,多中心研究
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更新日期:2012-09-24 00:00:00
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pub_type: 杂志文章
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pub_type: 杂志文章
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更新日期:2012-10-24 00:00:00
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pub_type: 杂志文章,meta分析
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pub_type: 已发布勘误
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pub_type: 杂志文章
doi:10.1186/1471-2261-14-49
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pub_type: 杂志文章
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pub_type: 杂志文章
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pub_type: 杂志文章,多中心研究
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pub_type:
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pub_type: 杂志文章,meta分析
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