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临床试验/NCT03504891
NCT03504891Unknown1 期

Cardiac MRI for Optimal Heart Failure Outcomes With CRT Upgrades

University of Virginia2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年1月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
入组人数
50
试验地点
2
主要终点
CRT Response

研究概览

简要总结

This study will investigate the use of cardiac MRI in patients with standard ICDs and pacemakers to inform how cardiac resynchronization therapy (CRT) can best be implemented in these patient and which patients are the best candidates for CRT.

详细描述

The scientific premise of this proposal is that left and right ventricular (LV and RV) structural characteristics in patients with existing cardiac implantable electronic devices and heart failure who may benefit from an upgrade to a cardiac resynchronization therapy (CRT) device can be assessed very effectively using cardiac MRI using sequences designed for post-device imaging. Furthermore, a comparative analysis of the differences in LV/RV structural characteristics in patients with existing devices referred for CRT upgrades versus those with de novo CRT implants is expected to be very useful for developing effective strategies for optimal patient selection for CRT upgrades and implementation of CRT upgrades in appropriate patients. Patient selection for CRT upgrades is very important considering that complication rates are higher than in de novo CRT procedures and nonresponse rates are still high. With this in mind, we are performing a study of 100 patients, including 50 prospectively enrolled patients with LVEF less than or equal to 0.35 and New York Heart Association class II-III heart failure, who will be compared with an existing cohort of 50 patients with recent de novo CRT implants, pre-CRT MRIs, and response data. The 50 prospectively enrolled patients having CRT upgrades will undergo a pre-CRT cardiac MRI, pre-CRT/post-CRT echocardiography, and pre-CRT/post-CRT cardiopulmonary exercise testing. In the first aim, we will assess differences in cardiac MRI findings between CRT upgrade patients and de novo CRT patients. In the second aim, we will assess the impact of cardiac MRI findings on LV reverse remodeling and cardiopulmonary capacity in the two groups. In summary, we propose a comprehensive prospective CRT/MRI study in CRT upgrade patients with comparison to a complete MRI dataset of patients with de novo CRT implants in order to identify key differences in MRI findings in these cohorts and the impact of these MRI-based scar and activation findings on clinical outcomes. We expect that our results will have a significant public health impact for patients with heart failure referred for CRT upgrades.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
25 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Undergoing upgrade from an existing pacemaker or ICD to a CRT device.

排除标准

  • inability to provide informed consent
  • pregnancy
  • presence of metal embedded in the body due to prior accident or injury, as documented by skull films or other imaging
  • cerebral aneurysm clips
  • cochlear implants
  • other metallic implants known to be contraindications to MRI (pacemakers and ICDs are allowed)
  • severe claustrophobia
  • acute kidney injury
  • acute renal failure
  • gadolinium allergy
  • abandoned leads

研究组 & 干预措施

MRI Prior to de novo CRT Implants

Active Comparator

MRI will be performed prior to de novo CRT implants.

干预措施: MRI prior to de novo CRT (Diagnostic Test)

MRI Prior to CRT for Upgrades

Experimental

MRI will be performed prior to CRT upgrade.

干预措施: MRI prior to CRT Upgrade (Diagnostic Test)

结局指标

主要结局

CRT Response

时间窗: 6 months

CRT Response Based on Change in LVESV After CRT

次要结局

  • Improvement in Short Form (36) Health Survey(6 months)
  • Improvement in Peak Oxygen Consumption(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kenneth Bilchick, MD

Associate Professor of Medicine

University of Virginia

研究点 (2)

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