低侵襲冠動脈手術と胸骨切開による冠動脈バイパス移植術の比較試験
基本情報
- NCT ID
- NCT03447938
- ステータス
- 募集中
- 試験のフェーズ
- 該当なし
- 試験タイプ
- 介入
- 目標被験者数
- 176
- 治験依頼者名
- Ottawa Heart Institute Research Corporation
概要
MICS CABG (Minimally invasive coronary surgery), where coronary artery bypass grafting (CABG) is completed through a small incision over the left chest, has evolved to become a safe and less invasive alternative to conventional sternotomy CABG. Several observational studies have suggested significantly shorter time to return to physical activity for MICS CABG patients compared to sternotomy CABG patients. A randomized study is warranted to validate these findings, provide higher level of evidence, and potentially lead to changes in practice. The MIST Trial is a multi-centre, prospective, open label, randomized control trial comparing quality of life and recovery in the early post-operative period, between patients undergoing MICS CABG versus patients undergoing sternotomy CABG. Patients referred for isolated CABG for multi-vessel coronary artery disease and deemed technically suitable for sternotomy CABG as well as for MICS CABG are considered for enrollment into the trial. Quality of life questionnaires (The SF-36, Seattle Angina Questionnaire and EQ-5D-5L) will be used to assess the quality of life and recovery in patients undergoing sternotomy CABG or MICS CABG at 1 month, 3 months, 6 months and 12 months follow up.
対象疾患
介入
依頼者(Sponsor)
実施施設 (1)
東京ベイ・浦安市川医療センター
Urayasu, Chiba, Japan(NOT_YET_RECRUITING)