跳至主要内容
临床试验/NCT05049421
NCT05049421已完成不适用

Right Ventricular Function After Coronary Artery Bypass Grafting The SWEDEGRAFT Right-Heart-Substudy

Aarhus University Hospital Skejby1 个研究点 分布在 1 个国家目标入组 207 人开始时间: 2021年8月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
207
试验地点
1
主要终点
3D right ventricular ejection fraction

研究概览

简要总结

BACKGROUND

Right ventricular dysfunction is a common echocardiographic finding after cardiac surgery. Pericardial disruption has been suggested as the most probable cause as the phenomenon occurs within minutes after pericardial incision.

The investigators suspect that validated two-dimensional echocardiographic measures for right ventricular function might not reflect the altered RV contraction pattern including paradoxical interventricular septal motion and reduced long-axis function following open cardiac surgery.

The present study aims to determine the prevalence and scale of right ventricular dysfunction two years after CABG by applying the latest available two- and three-dimensional echocardiographic technology in right ventricular evaluation. In addition, the investigators investigate the impact of right ventricular dysfunction on functional outcome.

METHODS

The Right-Heart-Study is an observational substudy of the SWEDEGRAFT trial at Aarhus University Hospital in Denmark. SWEDEGRAFT is a nordic, multicenter, prospective, randomized, register-based, clinical trial (ClinicalTrials.gov Identifier: NCT03501303; Ragnarsson 2020). Patients for the current Right-Heart-Substudy will be recruited amongst the 269 patients included in the SWEDEGRAFT trial at Aarhus University Hospital from 10 September 2018 to 25 May 2020. Patients are enrolled at the time of SWEDEGRAFT follow-up with cardiac-CT (approximately 30 months after CABG). After written informed consent, we perform additional full 2D and 3D echocardiography with special focus on RV function, collect patient-reported data on functional outcome, and measure brain natriuretic peptide and hemoglobin levels.

详细描述

Complete study protocol attached

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • SWEDEGRAFT inclusion criteria:
  • First-time non-emergent CABG patients
  • Need for at least one vein graft
  • Able to provide informed consent and accepted for isolated primary CABG.
  • Additional inclusion criteria for the Right-Heart-Substudy:
  • Ability to meet for follow-up visit

排除标准

  • SWEDEGRAFT exclusion criteria:
  • No greater saphenous vein grafts available (previous vein stripping or poor vein quality)
  • Age > 80 years at the time of inclusion
  • Allergy to contrast dye
  • Renal failure with eGFR <15 ml/min at primary inclusion
  • Coagulation disorders
  • Excessive risk of wound infection
  • Participation in other interventional trial on grafts
  • Any condition that seriously increases the risk of non-compliance or loss of follow-up
  • Pregnant women or women of child bearing potential without negative pregnancy test
  • Additional inclusion criteria for the Right-Heart-Substudy:
  • Inability to cooperate to transthoracic echocardiography

结局指标

主要结局

3D right ventricular ejection fraction

时间窗: 30 months postoperative

Right ventricular function assessed by 3D echocardiography

Right ventricular strain

时间窗: 30 months postoperative

Derived from two-dimensional speckle-tracking

次要结局

  • Perceived exertion during exercise(30 months postoperative)
  • Degree of dyspnea at exertion(30 months postoperative)
  • Long-term Major Adverse Cardiac and Cerebrovascular Events(5 and 10 years after CABG)
  • Disease-specific health-related quality of life(30 months postoperative)
  • Pro-Brain Natriuretic Peptide(30 months postoperative)

研究者

发起方
Aarhus University Hospital Skejby
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ivy susanne Modrau, MD

Consultant Cardiac Surgeon, Associate Professor

Aarhus University Hospital Skejby

研究点 (1)

Loading locations...

相似试验