Rationale and design for the Defibrillators to Reduce Risk by Magnetic Resonance Imaging Evaluation (DETERMINE) trial.
Rationale and design for the Defibrillators to Reduce Risk by Magnetic Resonance Imaging Evaluation (DETERMINE) trial.
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DOI：
10.1111/j.1540-8167.2009.01503.x
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发表时间：
2009-09
影响因子：
2.7
通讯作者：
Goldberger JJ
中科院分区：
文献类型：
--
作者：
Kadish AH;Bello D;Finn JP;Bonow RO;Schaechter A;Subacius H;Albert C;Daubert JP;Fonseca CG;Goldberger JJ
心脏磁共振成像（CMR）可以准确地确定梗死面积。先前使用间接方法和CMR评估梗死面积的研究表明，心肌梗死面积较大的患者预后较差。植入式心律转复除颤器（ICD）已被证明可以提高严重左心室（LV）功能障碍患者的生存率。然而，大多数心脏骤停发生在射血分数较高的患者中。通过磁共振成像评价降低风险的除颤器研究（DETERMINE）是一项在冠状动脉疾病（CAD）和轻度至中度LV功能障碍患者中进行的前瞻性、多中心、随机化临床试验。本试验的目的是检验以下假设：与随机接受药物治疗的患者相比，随机接受ICD加适当药物治疗的梗死面积≥ LV质量10%的患者的死亡率降低。将对CAD患者进行电影和心肌延迟造影CMR。主要终点是全因死亡。至少有10，000名CAD患者将接受CMR。目标入组人数为1，550例患者，估计入组期为36个月。将在末例患者随机化后对患者进行24个月的随访。估计随访期间将发生330例死亡。本研究有把握检测ICD治疗的死亡率降低28%。DETERMINE试验将评估ICD治疗改善CAD、轻度至中度LV功能不全和通过CMR测量的梗死面积≥ LV质量10%的患者生存率的疗效。
Cardiac magnetic resonance imaging (CMR) can accurately determine infarct size. Prior studies using indirect methods and CMR, to assess infarct size have shown that patients with larger myocardial infarctions have worse prognoses. Implantable cardioverter defibrillators (ICD) have shown to improve survival among patients with severe left ventricular (LV) dysfunction. However, the majority of cardiac arrests occur in patients with higher ejection fractions. The Defibrillators To Reduce Risk By Magnetic Resonance Imaging Evaluation study (DETERMINE) is a prospective, multi-center, randomized, clinical trial in patients with coronary artery disease (CAD) and mild to moderate LV dysfunction. The purpose of this trial is to test the hypothesis that patients with an infarct size ≥10% of LV mass, randomized to ICD plus appropriate medical therapy will have reduced mortality as compared to patients randomized to medical therapy. Cine and myocardial delayed contrast CMR will be performed in patients with CAD. The primary endpoint is death from any cause. At least 10,000 patients with CAD will undergo CMR. The target enrollment is 1,550 patients with an estimated 36-month enrollment period. Patients will be followed for 24 months after the last patient randomization. 330 deaths are estimated to occur during the follow-up period. This study is powered to detect a 28% reduction in mortality by ICD therapy. The DETERMINE trial will assess the efficacy of ICD therapy to improve survival among patients with CAD, mild to moderate LV dysfunction and infarct size ≥10% of LV mass as measured by CMR.
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影响因子：
37.8
作者：
Adams, RJ;Antman, EM;Kavey, REW
通讯作者：
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37.8
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作者：
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