Study of Feasibility for Surgical Patients Undergoing Heart Surgery With the Mammary Arteries: Reviewing Infection, Occlusion Rates and Pain Assessments. (COMFORT pilot)
Pilot Study for COMFORT Trial Comparative Outcomes of Mammary Artery Harvesting: Infection, Occlusion Rates and Thoracic Pain Assessment
The Pilot study for the COMFORT Trial is a single centre trial to determine the feasibility of the full COMFORT Trial.
The main COMFORT Trial will be a multi-centre trial to investigate the coronary artery bypass grafting outcomes when harvesting the Left Internal Mammary Artery (LIMA) using a skeletonized approach (artery is isolated without the surrounding veins, fascia and nerves) compared to harvesting the LIMA using a non-skeletonized approach (artery is isolated with the surrounding veins, fascia and nerves). Harvesting the LIMA with the non-skeletonized approach is the standard technique. Participants will complete a Coronary Artery Tomography scan at 1 year to determine if the LIMA graft remains open. Follow up of the participants will continue until 2 years post surgery.
調査の概要
状態
条件
詳細な説明
Prior to expansion of the COMFORT Trial to multiple centres, a pilot phase will be conducted at UOHI to evaluate the feasibility of implementing the study protocol within the local clinical and research environment.
Conducting an initial pilot phase allows the study team to assess the practical aspects of trial implementation, including patient screening and recruitment, informed consent procedures, randomization workflow, intraoperative documentation of the harvesting technique, and completion of study data collection.
The pilot phase will also allow evaluation of study logistics related to follow-up procedures, including postoperative data collection and coordination of protocol-mandated computed tomography angiography (CTA). This process will help identify and address any operational challenges prior to broader trial implementation across participating centres.
Participants enrolled during the pilot phase will undergo the same randomized study procedures described in the main COMFORT Trial protocol. Data collected during this phase may contribute to the overall COMFORT Trial dataset, subject to confirmation that the pilot procedures align with the finalized trial protocol and statistical analysis plan.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Nahya Awada, BSN, MCR, Ph.D.
- 電話番号：613-696-7000
- メール：naawada@ottawaheart.ca
研究場所
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Ontario
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Ottawa、Ontario、カナダ、K1Y 4W7
- 募集
- University of Ottawa Heart Institute
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コンタクト：
- Nahya Awada, BSN, MCR, Ph.D.
- 電話番号：613-696-7000
- メール：naawada@ottawaheart.ca
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Age 18 years or older
- Undergoing isolated CABG surgery with median sternotomy and a planned LIMA-LAD graft.
- Provision of written informed consent.
Exclusion Criteria:
- Non-sternotomy surgical approach (e.g., minimally invasive, thoracotomy)
- Emergency surgery (defined as surgery required within 24 hours or presentation
- History of prior ternotomy
- Currently receiving systemic antibiotics or with an active bacterial infection at the time of surgery
- History of chronic sternal pain prior to the index surgery.
- Known left subclavian artery stenosis (>50%)
- Previous radiation therapy to the chest
- Known allergy or contraindication to iodinated contrast media that cannot be managed with premedication.
- Estimated glomerular filtration rate (eGFR) <30 ml/min/1.73m2 at baseline (relative contraindications to CTA contrast). The eGFR will be determined by each participating institution according to their standard practice.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Skeletonized Harvesting of LIMA
LIMA is harvested using the skeletonized harvesting technique.
This technique isolates the artery without the surrounding satellite veins, endothoracic fascia, and intercoastal nerves.
|
This intervention is the surgical technique used to harvest the artery that will be used to perform the bypass surgery.
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アクティブコンパレータ：Non-Skeletonized Harvesting of LIMA
LIMA is harvested using the non-skeletonized harvesting technique.
This technique isolates the artery with the surrounding satellite veins, endothoracic fascia, and intercoastal nerves.
|
This intervention is the surgical technique used to harvest the artery that will be used to perform the bypass surgery.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Feasibility of Implementation
時間枠：2 years
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Combined assessment of screening, recruitment, randomization, surgical protocol adherence, and completion of study data collection and follow up procedures.
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2 years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Recruitment Rate
時間枠：Activation of study to 6 months.
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Measurement of rate of participant enrollment to determine ability to efficiently recruit into the main trial.
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Activation of study to 6 months.
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Protocol Adherence
時間枠：activation to 2 years per participant.
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Ability to complete all protocol required tests and assessments.
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activation to 2 years per participant.
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Completeness of Study Data Collection
時間枠：activation to 2 years per participant.
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Measurement of ability to collect all protocol-required data.
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activation to 2 years per participant.
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Completion of CTA at 1 year.
時間枠：enrollment to 1 year.
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Feasibility of completing the CTA at 1 year for all participants.
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enrollment to 1 year.
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協力者と研究者
捜査官
- 主任研究者：Fraser Rubens, MD, MSc.、Ottawa Heart Institute Research Corporation
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 20260183-01H
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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