Insights From the FAST-TRACK CABG Trial: a Clinical Outcome Study in Patient With Previous Surgical Revascularization for Complex Three-vessel or Left Main Coronary Artery Disease Based on Coronary Computed Tomography Angiogram, and Fractional Flow Reserve Derived by Computed Tomography (FAST-CABG)
FAST-CABG: Insights From the FAST-TRACK CABG Trial: a Clinical Outcome Study in Patient With Previous Surgical Revascularization for Complex Three-vessel or Left Main Coronary Artery Disease Based on Coronary Computed Tomography Angiogram, (CCTA) and Fractional Flow Reserve Derived by Computed Tomography (FFRCT)
調査の概要
状態
条件
詳細な説明
The present study is a observational, prospective, multicenter European study aims to explore in the population of FAST-TRACK CABG the patient-reported outcome measures (by Seattle Angina Questionnaire SAQ) as well as major adverse cerebral and cardiovascular events (MACCE) in FAST TRACK CABG population. Patients meeting all inclusion criteria will be asked to sign an informed consent document.
Clinical outcomes will be collected using Seattle Angina Questionnaire (SAQ). Will be also collected the New York Heart Association (NYHA); MACCE and All-cause death, components of MACCE and cardiovascular hospitalization.
During this visit, the value of Lp (a), which was previously dosed according to the guidelines, will also be recorded
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前:Gianluca Pontone, MD
- 電話番号:+39 0258002574
- メール:gianluca.pontone@cardiologicomonzino.it
研究連絡先のバックアップ
- 名前:Saima Mushtaq, MD
- 電話番号:+39 0258002679
- メール:saima.mushtaq@cardiologicomonzino.it
研究場所
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MI
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Milan、MI、イタリア、20131
- 募集
- Centro Cardiologico Monzino; IRCCS
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コンタクト:
- Chiara Centenaro
- 電話番号:+39 0258002031
- メール:chiara.centenaro@cardiologicomonzino.it
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-
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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Patients who have analyzable pre-CABG CCTA imaging and received a successful CCTA-guided plus FFRCT CABG procedure.
- Patient with known level of Lp(a) or with possibility to perform the test
- Patent able to provide written informed consent as approved by the Ethical Committee
Exclusion Criteria:
- Patients without pre-CABG CCTA imaging or those with who did not receive surgical revascularization.
- Current treatment with lipoprotein apheresis
- Patients who refuse to receive clinical follow-up
- Unable to give Informed Consent
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
コホートと介入
グループ/コホート |
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Prospective Cohort
Patients enrolled in a prior clinical trial undergoing follow-up for the assessment of patient-reported outcomes (SAQ), MACCE, and biomarker correlations, including serum lipoprotein(a) levels
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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 |
|---|---|---|
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Patient-Reported Outcomes assessed by Seattle Angina Questionnaire (SAQ)
時間枠:May 2026
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The primary aim of this study is to explore in the population of FAST-TRACK CABG the patient-reported outcome measures (by Seattle Angina Questionnaire SAQ) in FAST TRACK CABG population.
In coronary artery disease, the Seattle Angina Questionnaire (SAQ) has emerged as the most commonly used measure of disease-specific health status to quantify patients' symptoms of angina and the degree to which their angina impacts their function and quality of life.
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May 2026
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Major Adverse Cerebral and Cardiovascular Events
時間枠:May 2026
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Occurrence of major adverse cerebral and cardiovascular events, including all-cause death, myocardial infarction, stroke, and repeat revascularization.
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May 2026
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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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Correlation of Lipoprotein(a) with Cardiovascular Outcomes in Complex Coronary Artery Disease
時間枠:May 2026
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The secondary objectives of this study are to evaluate if serum Lp(a) levels improve the predictive capacity of imaging biomarkers in predicting MACCE; to evaluate the correlation between serum Lp(a) levels and CCTA-derived total plaque volume, high risk plaque features, in patients with complex three-vessel or left main coronary artery disease (CAD) participating in the FASTTRACK CABG Trial.
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May 2026
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協力者と研究者
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
その他の研究ID番号
- L2-347
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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