The CORE - μFR Clinical Trial
μFR -Guided Complete Revascularization in Patients With Acute Coronary Syndromes
Acute coronary syndromes (ACS) are frequently associated with multivessel coronary artery disease (CAD), and current guidelines recommend complete revascularization beyond the culprit lesion. Angiography-guided PCI is the standard approach, but anatomical assessment does not always reflect the functional significance of intermediate lesions, while FFR-guided strategies are limited by the need for pressure wires and hyperemia. Murray-law-based quantitative flow ratio (μFR) is a wire-free angiography-derived physiological index that may improve decision-making for revascularization in ACS patients.
The Core-μFR is an investigator-driven, multicenter, randomized, open-label and prospective trial designed to evaluate whether μFR can act as a gatekeeper for complete revascularization in patients with ACS and multivessel disease by identifying non-culprit lesions that truly require PCI.
Patients with ACS (either STEMI or NSTE-ACS) undergoing primary PCI will be considered eligible if they present multivessel CAD on visual assessment with the intention to treat the non-culprit vessel in a staged procedure within the same hospitalization. After the pPCI, eligible patients will be randomized to either group A or group B and μFR will be performed in a blinded fashion with the operator unaware of the functional result. Patients in group A will undergo a staged PCI of all NCVs guided by coronary angiography, as per standard of care. In group B, μFR will be used as a gatekeeper for staged revascularization. Operators will only be informed whether at least one non-culprit vessel is μFR-positive, without disclosure of the specific vessel involved or the μFR values. If at least one non-culprit vessel has μFR ≤0.80, patients will undergo angiography-guided PCI of all non-culprit vessels previously deemed suitable for treatment by visual assessment. If μFR is >0.80 in all non-culprit vessels, staged PCI will be deferred and the patient will be discharged without further revascularization. Finally, to test the functional reproducibility, a blinded post-hoc μFR assessment will be performed on the baseline angiograms of the staged procedures in all the patients undergoing complete revascularization. Clinical follow-up will be performed at 30 days and 1 year from randomization.
調査の概要
状態
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：Emanuele Barbato, MD, PhD
- 電話番号：+39 06 3377 6115
- メール：emanuele.barbato@uniroma1.it
研究連絡先のバックアップ
- 名前：Emanuele Gallinoro, MD, PhD
- 電話番号：+39 06 3377 5005
- メール：egallinoro@gmail.com
研究場所
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RM
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Roma、RM、イタリア、00189
- Azienda ospedaliero - universitaria Sant'Andrea
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コンタクト：
- Emanuele Barbato, MD, PhD
- 電話番号：+39 06 3377 6115
- メール：emanuele.barbato@uniroma1.it
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コンタクト：
- Emanuele Gallinoro, MD, PhD
- 電話番号：+39 06 3377 5005
- メール：egallinoro@gmail.com
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-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Patients presenting with ACS within 72 hours of successful culprit PCI
Residual coronary artery disease, defined as at least one additional stenosis in any non-culprit vessel (NCV) with the following characteristics:
- at least 50% diameter stenosis by visual assessment
- a vessel diameter of at least 2.5 mm
- amenable to successful PCI
Exclusion Criteria:
- Cardiogenic shock or severe heart failure (NYHA class ≥III)
- Severely impaired renal function: creatinine >2 mg/dl or estimated glomerular filtration rate (eGFR) <30 ml/min/1,73 m²
- Allergy to iodine-containing contrast agents which cannot be adequately pre-medicated
- Pregnancy or intention to become pregnant during the trial
- Life expectancy less than one year
- Ambiguity in the identification of the culprit vessel/lesion
- Clinical presentation as myocardial infarction and non-obstructive coronary artery disease (MINOCA) and/or Tako-Tsubo Syndrome
- Any ambiguity in the diagnosis of ACS
- Inability to provide informed consent
- Patients with only one coronary artery lesion with diameter stenosis >90% and/or TIMI flow <3
- Patients in whom the NCV is treated at the time of the index procedure
- An interrogated lesion is at the site of a myocardial bridge
- An interrogated lesion is a culprit lesion responsible for the acute myocardial infarction
- An interrogated lesion is in a bypass graft
- Poor angiographic image quality precluding vessel contour detection or with suboptimal contrast opacification
- Severe vessel overlap in the stenosed segment or severe tortuosity of any interrogated vessel deemed not amenable to μFR measurement
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：Group A - Angiography-guided PCI (standard strategy)
Patients will undergo a staged PCI of all non-culprit vessels identified before randomization according to angiography and operator judgment, as per standard of care.
μFR will be analyzed off-line by the core lab and will not be available to the operator.
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staged PCI of all NCVs will be performed as per standard of care
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実験的：Group B - μFR based-PCI
μFR will be analyzed off-line by the core lab.
Coronary revascularization will be deferred if the μFR > 0.80 in all the non-culprit vessels identified before randomization.
If μFR ≤ 0.80 in at least one non-culprit vessels identified before randomization, patients will undergo a staged PCI.
Operators remain blinded to μFR values, and treatment of vessels is based on angiography only.
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staged PCI will be deferred if the μFR > 0.80 in all the NCVs or performed if the μFR is ≤ 0.80 in at least one NCVs
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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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Primary efficacy endpoint
時間枠：Periprocedural
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Number of stents implanted and number of procedures
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Periprocedural
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Primary safety endpoint
時間枠：1 year
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MACE (major adverse cardiovascular event) defined as the composite of all-cause mortality, non-culprit vessel unplanned revascularization, non-fatal myocardial infarction (defined according to the Fourth Universal Definition of Myocardial Infarction, including procedural MI and spontaneous MI)
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1 year
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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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Inappropriate revascularization
時間枠：Periprocedural
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Inappropriate revascularization according to μFR value
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Periprocedural
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Change in clinical decision making
時間枠：Periprocedural
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Change in clinical decision making about revascularization strategy from intended PCI to medical therapy
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Periprocedural
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μFR reproducibility
時間枠：Periprocedural
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Test-re-test repeatability of μFR
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Periprocedural
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Length of stay
時間枠：Periprocedural
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Duration of hospitalization
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Periprocedural
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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 (推定)
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
- Rif. 8306, Prot. 0284/2026
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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Angiography-guided PCIの臨床試験
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Clinica Universidad de Navarra, Universidad de...まだ募集していません前立腺がん（前立腺切除後）
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Duke UniversityUniversity of Pennsylvania; National Institutes of Health (NIH)募集