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En ny teknik för att mäta hjärtas mikrovaskulära funktion hos patienter som upplever hjärtattack (ConMICRO)

28 september 2026 uppdaterad av: Khaled Ziada, MD, The Cleveland Clinic

STEMI-CST: Bedömning av koronarmikrovaskulär dysfunktion efter hjärtinfarkt av st-elevation

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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Diagnostiskt test: Continuous Saline Thermodilution

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Namn: Khaled Ziada, MD
Telefonnummer: 216-444-0926
E-post: ziadak@CCF.ORG

Studera Kontakt Backup

Namn: Vincent Chen, MD
Telefonnummer: 440-226-1994
E-post: chenv3@ccf.org

Studieorter

Förenta staterna
- Ohio
  - Cleveland, Ohio, Förenta staterna, 44195
    - Rekrytering
    - Cleveland Clinic
    - Huvudutredare:
      
      Khaled Ziada, MD
    - Kontakt:
      
      Vincent Chen, MD
      
      Telefonnummer: 440-226-1994
      
      E-post: CHENV3@ccf.org
    - Underutredare:
      
      Vincent Chen, MD

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Observationsmodeller: COHORT
Tidsperspektiv: PROSPECTIVE

Vad mäter studien?

Primära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Microvascular resistance reserve (MRR) Tidsram: At enrollment	Calculated index to assess coronary microvascular dysfunction (Q_hyperemia/Q_rest)*(Pa_rest/Pd_hyperemia)	At enrollment

Sekundära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Change in LV Wall Motion Summed Score Tidsram: 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 Tidsram: 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 Tidsram: Within 3 days of hospital discharge	Presence of microvascular obstruction on cardiac MRI	Within 3 days of hospital discharge

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

The Cleveland Clinic

Samarbetspartners

Abbott

Utredare

Huvudutredare: Khaled Ziada, MD, The Cleveland Clinic

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

29 maj 2025

Primärt slutförande (Beräknad)

31 december 2027

Avslutad studie (Beräknad)

31 december 2027

Studieregistreringsdatum

Först inskickad

24 januari 2025

Först inskickad som uppfyllde QC-kriterierna