심장 마비가 발생한 환자에서 심장의 미세 혈관 기능을 측정하는 새로운 기술 (ConMICRO)
STEMI-CST : 연속 식염수 열 변질을 사용한 ST 차단 심근 경색 후 관상 동맥 미세 혈관 기능 장애의 평가
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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Khaled Ziada, MD
- 전화번호: 216-444-0926
- 이메일: ziadak@CCF.ORG
연구 연락처 백업
- 이름: Vincent Chen, MD
- 전화번호: 440-226-1994
- 이메일: chenv3@ccf.org
연구 장소
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Ohio
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Cleveland, Ohio, 미국, 44195
- 모병
- Cleveland Clinic
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수석 연구원:
- Khaled Ziada, MD
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연락하다:
- Vincent Chen, MD
- 전화번호: 440-226-1994
- 이메일: CHENV3@ccf.org
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부수사관:
- Vincent Chen, MD
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
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.
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: PROSPECTIVE
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Microvascular resistance reserve (MRR)
기간: At enrollment
|
Calculated index to assess coronary microvascular dysfunction (Q_hyperemia/Q_rest)*(Pa_rest/Pd_hyperemia) |
At enrollment
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in LV Wall Motion Summed Score
기간: From 1-day echo to 3-month routine follow up echo
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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
기간: From 1-day echo to 3-month routine follow up echo
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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
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|
Presence of microvascular obstruction
기간: Within 3 days of hospital discharge
|
Presence of microvascular obstruction on cardiac MRI |
Within 3 days of hospital discharge
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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