心臓発作を経験している患者における心臓の微小血管機能を測定するための新しい技術 (ConMICRO)
STEMI-CST：連続生理食塩水希釈を使用したSTエレベーションの心筋梗塞後の冠動脈微小血管機能障害の評価
The goal of this observational study to measure the heart's microvascular function in the setting of a myocardial infarction (MI), or heart attack, using a method called continuous saline thermodilution (CST). The participants will include people who are experiencing MI from sudden and complete blockage of a coronary artery requiring immediate balloon and/or stent therapy. After getting the balloon and/or stent therapy, participants will have their heart's microvascular system tested using CST. The main questions it aims to answer are:
- What measurements using CST can we expect from the heart's microvascular system during a treated MI?
- Can CST measurements during a treated MI predict the amount of heart muscle that is injured and that recovers?
For this study, participants will undergo measurement of their heart's microvascular function after balloon and/or stent therapy for the MI. They will then receive an MRI scan of the heart several days after the MI.
調査の概要
詳細な説明
This will be a non-interventional, prospective, descriptive analysis on a cohort of patients experiencing ST-elevation myocardial infarction (STEMI) who present to the Cleveland Clinic cardiac catheterization laboratory (CCL) for emergent primary percutaneous coronary intervention (PCI). The aim is to study acute coronary microvascular dysfunction using the method of continuous saline thermodilution to provide absolute measurements of coronary blood flow, coronary microvascular resistance, and microvascular resistance reserve (MRR) following primary PCI for STEMI patients.
Adult patients experiencing acute STEMI who present to the catheterization laboratory for emergent cardiac catheterization for STEMI, <24 hours after symptom onset, who undergo primary PCI to an IRA. Only those able to provide initial oral consent upon CCL presentation and confirmatory written consent following cardiac catheterization will be included in the study.
Study endpoints are part of usual standard practice, and include clinic visits with updated medical histories and physical examination, and echocardiography. Clinical endpoints of interest will include mortality, incident heart failure, anginal symptoms, and standard major adverse cardiac events including cardiac death, nonfatal MI, urgent coronary revascularization, or hospitalization for unstable angina.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Khaled Ziada, MD
- 電話番号：216-444-0926
- メール：ziadak@CCF.ORG
研究連絡先のバックアップ
- 名前：Vincent Chen, MD
- 電話番号：440-226-1994
- メール：chenv3@ccf.org
研究場所
-
-
Ohio
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Cleveland、Ohio、アメリカ、44195
- 募集
- Cleveland Clinic
-
主任研究者：
- Khaled Ziada, MD
-
コンタクト：
- Vincent Chen, MD
- 電話番号：440-226-1994
- メール：CHENV3@ccf.org
-
副調査官：
- Vincent Chen, MD
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Adults presenting to catheterization lab within 24 hours of ischemic symptom onset with intent for emergent primary PCI due to STEMI on ECG or who have failed thrombolytic therapy and present for pharmaco-invasive management of STEMI.
説明
Inclusion Criteria:
- Adults (persons >18 years old) presenting to Cleveland Clinic cardiac catheterization lab within 24 hours of symptom onset, with clinical and EKG findings concerning for STEMI, with intent to undergo emergent primary PCI, who have culprit artery identified on diagnostic angiography
- Adults (persons >18 years old) presenting to Cleveland Clinic cardiac catheterization lab for pharmaco-invasive management of failed fibrinolysis, with intent to undergo emergent PCI, who have culprit artery identified on diagnostic angiography
- On-call treating interventional cardiologist is trained in the method of continuous saline thermodilution for coronary microvascular assessment
Exclusion Criteria:
- No evidence of coronary obstruction on diagnostic angiography (e.g., Takotsubo, myocarditis leading to STEMI activation).
- Patients in hemodynamic shock
- Culprit artery <3.0 mm in diameter.
- Culprit artery being a bypass graft
- Patients physically unable to tolerate additional time required to conduct coronary microvascular testing after primary PCI.
- Patients with eGFR <30 mL/min/1.73m2 are excluded from contributing cardiac MRI data
- Patients with standard contraindications to CMR (e.g., pacemakers, cochlear implants, certain prosthetic heart valves, certain surgical implants) are excluded from contributing cardiac MRI data
- Unable to provide verbal and written consent
- Pregnancy
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
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
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 |
|---|---|---|
|
Microvascular resistance reserve (MRR)
時間枠：At enrollment
|
Calculated index to assess coronary microvascular dysfunction (Q_hyperemia/Q_rest)*(Pa_rest/Pd_hyperemia) |
At enrollment
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in LV Wall Motion Summed Score
時間枠：From 1-day echo to 3-month routine follow up echo
|
Global wall motion abnormality score by echo based on 16 segment model (0= normal, 1=mild hypokinetic, 2= hypokinetic, 3= severely hypokinetic, 4= akinetic, 5= aneurysmal) |
From 1-day echo to 3-month routine follow up echo
|
|
Change in LVEF
時間枠：From 1-day echo to 3-month routine follow up echo
|
Left ventricular ejection fraction as quantified by routine baseline echo to routine follow up echo |
From 1-day echo to 3-month routine follow up echo
|
|
Presence of microvascular obstruction
時間枠：Within 3 days of hospital discharge
|
Presence of microvascular obstruction on cardiac MRI |
Within 3 days of hospital discharge
|
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。