Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

8. februar 2022 opdateret af: 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.

Studieoversigt

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

426

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Studieleder: Hou, Beijing Anzhen Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Forventet)

1. marts 2022

Primær færdiggørelse (Forventet)

1. juli 2024

Studieafslutning (Forventet)

1. december 2024

Datoer for studieregistrering

Først indsendt

30. december 2021

Først indsendt, der opfyldte QC-kriterier

8. februar 2022

Først opslået (Faktiske)

9. februar 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. februar 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. februar 2022

Sidst verificeret

1. februar 2022

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner