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Timing of Complete Revascularization in Patients With ST-segment Elevation Myocardial Infarction And Multivessel Disease (TERMINAL)

8. februar 2022 oppdatert av: Xiaotong Hou, Beijing Anzhen Hospital

Timing of Complete Revascularization in Patients With ST-segment Elevation Myocardial Infarction And Multivessel Disease-A Multi-center Randomized Controlled Trial

At present, the two treatment strategies of opening non infarct related arteries (non IRA) simultaneously or by stages after emergency percutaneous coronary intervention (PCI) in patients with acute ST segment elevation myocardial infarction (STEMI) complicated with multi vessel disease (MVD) are still controversial. In our previous retrospective analysis, there was no significant difference between complete revascularization (CR) and staged CR at Anzhen Hospital in the cases of cardiac death, reinfarction, stroke, proportion of revascularization and hospitalization rate of heart failure.

Studieoversikt

Detaljert beskrivelse

The literature reports on the benefits of two CR strategies of opening non IRA simultaneously or by stages after IRA treatment in STEMI patients are inconsistent. This study intends to enroll 426 cases and divide into two groups to verify whether the occurrence of major cardiovascular adverse events (all-cause death, nonfatal myocardial infarction, ischemia driven revascularization and heart failure) in one year in immediately open non-IRA after successful emergency PCI of infarct related arteries in STEMI patients with MVD group is not inferior to staged (within 45 days) CR group. It can accumulate more evidence-based medical basis for the selection of better treatment schemes, so as to formulate optimized treatment schemes for clinic. To study when to open meaningful non IRA in acute STEMI complicated with MVD is of great guiding significance for CR after acute myocardial infarction. At the same time, it has important social significance and economic value for delaying or preventing cardiovascular events.

Studietype

Intervensjonell

Registrering (Forventet)

426

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

    • Beijing
      • Beijing, Beijing, Kina, 100029
        • Center for Cardiac Intensive Care, Beijing Anzhen Hospital, Capital Medical University

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. Onset of the spontaneous acute STEMI (24 hours).
  2. The anatomical structure of coronary artery is suitable for complete revascularization by PCI.
  3. It is suitable for PCI through radial artery or femoral artery.
  4. Be able to fully identify Infarct-related artery(IRA).
  5. In addition to IRA, in the vessels of lumen diameter is 2.25mm or more, but less than 4.5mm. there is at least one non IRA's stenosis more than 70% observed in both planes, or 50% ~ 69% stenosis and fractional flow reserve (FFR) or Quantitative Flow Ratio (QFR) measured value is 0.80 or less.
  6. After IRA revascularization the thrombolysis in myocardial infarction (TIMI) blood flow is in grade 3.
  7. The hemodynamics of patients after IRA revascularization is stable, that is, systolic blood pressure ≥ 90mmHg, or blood pressure ≥ 90mmHg after catecholamines, and there is no clinical manifestation of hypoperfusion.
  8. Patient who has signed informed consent

Exclusion Criteria:

  1. Cardiogenic shock which means a group of clinical syndromes leading to cardiac dysfunction caused by various reasons, which meet the following criteria: A: continuous hypotension, systolic blood pressure < 90mmHg or mean arterial pressure decreased from baseline ≥ 30mmhg, more than 30min; B: cardiac index < 1.8l/min/m2, pulmonary congestion or elevated left ventricular filling pressure; c: Signs of organ perfusion damage (at least one): changes in mental state, wet and cold skin, oliguria, and increased serum lactic acid level.
  2. The duration of cardiopulmonary resuscitation is more than 10 minutes.
  3. Emergency coronary artery bypass grafting (CABG) is needed.
  4. Previous coronary-artery bypass grafting surgery.
  5. Hybrid revascularization is planned.
  6. Coronary dissection.
  7. Stent thrombosis.
  8. In stent restenosis, definition: A: target vessel diameter stenosis ≥ 50% at follow-up. b: The lumen loss at follow-up was larger than 50% of the net lumen gain after operation. c: The lumen diameter at follow-up and the minimum diameter loss measured immediately at stenting were 0.72 mm or more.
  9. Acute myocardial infarction complicated with severe mechanical complications, defined as acute severe mitral regurgitation, ventricular septal perforation and cardiac free wall rupture / pericardial tamponade.
  10. Severe renal failure (EGFR < 30ml / min) or dialysis treatment is required.
  11. Chronic total occlusion of main coronary artery.
  12. Complex bifurcation lesions requiring dual stent treatment.
  13. Stenosis of Left main coronary artery≥ 50% or stenosis of left anterior descending coronary artery and circumflex coronary artery ≥ 70%.
  14. Coronary, cerebrovascular or peripheral revascularization is planned.
  15. Cardiac surgery or other surgical treatment is planned.
  16. Contraindications to double antibody therapy [aspirin and P2Y12 inhibitor (clopidogrel or ticagrelor) for 3 months.
  17. pregnant woman.
  18. Patient who has participated in other clinical trials.
  19. Life expectancy < 1 year.
  20. Patient who is not suitable for inclusion in the study according to the operator's judgment.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Immediately CR group
Immediately open non-IRA after successful emergency PCI of IRA in STEMI patients with MVD
Immediately opening non-IRA after emergency opening IRA in STEMI patients with MVD
Aktiv komparator: Staged (within 45 days) CR group
Strategy of opening non-IRA by stages after emergency PCI of IRA in STEMI patients with MVD
Staged opening non-IRA after emergency opening IRA in STEMI patients with MVD

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Major Adverse Cardiovascular Event
Tidsramme: 1 year
Including All-cause death, Ischemia driven revascularization, Nonfatal myocardial infarction and Heart failure
1 year

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
All-cause death
Tidsramme: 1 year
All reasons of death
1 year
Ischemia driven revascularization
Tidsramme: 1 year
Myocardial ischemia needs to revascularize
1 year
Nonfatal myocardial infarction
Tidsramme: 1 year
A kind of Myocardial infarction which does not lead to death
1 year
Heart failure
Tidsramme: 1 year
Deterioration of heart function or acute heart failure
1 year
Cardiovascular related death
Tidsramme: 1 year
Died of cardiovascular diseases
1 year
Stent thrombosis
Tidsramme: 1 year
Thrombosis in stent
1 year
Dialysis or acute renal insufficiency
Tidsramme: 1 year
Dialysis or acute renal insufficiency occurred after operation
1 year
Bleeding events
Tidsramme: 1 year
Bleeding occurred after oral administration of dual antiplatelet drugs
1 year

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Studieleder: Hou, Beijing Anzhen Hospital

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Forventet)

1. mars 2022

Primær fullføring (Forventet)

1. juli 2024

Studiet fullført (Forventet)

1. desember 2024

Datoer for studieregistrering

Først innsendt

30. desember 2021

Først innsendt som oppfylte QC-kriteriene

8. februar 2022

Først lagt ut (Faktiske)

9. februar 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. februar 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. februar 2022

Sist bekreftet

1. februar 2022

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Nei

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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