- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05231226
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
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
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
- Navn: Xiaotong Hou, MD,PhD
- Telefonnummer: 8610 64456631
- E-post: xt.hou@ccmu.edu.cn
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:
- Onset of the spontaneous acute STEMI (24 hours).
- The anatomical structure of coronary artery is suitable for complete revascularization by PCI.
- It is suitable for PCI through radial artery or femoral artery.
- Be able to fully identify Infarct-related artery(IRA).
- 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.
- After IRA revascularization the thrombolysis in myocardial infarction (TIMI) blood flow is in grade 3.
- 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.
- Patient who has signed informed consent
Exclusion Criteria:
- 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.
- The duration of cardiopulmonary resuscitation is more than 10 minutes.
- Emergency coronary artery bypass grafting (CABG) is needed.
- Previous coronary-artery bypass grafting surgery.
- Hybrid revascularization is planned.
- Coronary dissection.
- Stent thrombosis.
- 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.
- Acute myocardial infarction complicated with severe mechanical complications, defined as acute severe mitral regurgitation, ventricular septal perforation and cardiac free wall rupture / pericardial tamponade.
- Severe renal failure (EGFR < 30ml / min) or dialysis treatment is required.
- Chronic total occlusion of main coronary artery.
- Complex bifurcation lesions requiring dual stent treatment.
- Stenosis of Left main coronary artery≥ 50% or stenosis of left anterior descending coronary artery and circumflex coronary artery ≥ 70%.
- Coronary, cerebrovascular or peripheral revascularization is planned.
- Cardiac surgery or other surgical treatment is planned.
- Contraindications to double antibody therapy [aspirin and P2Y12 inhibitor (clopidogrel or ticagrelor) for 3 months.
- pregnant woman.
- Patient who has participated in other clinical trials.
- Life expectancy < 1 year.
- 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.
Sponsor
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
- Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019 Jan 7;40(2):87-165. doi: 10.1093/eurheartj/ehy394. No abstract available. Erratum In: Eur Heart J. 2019 Oct 1;40(37):3096.
- Ibanez B, Roque D, Price S. The year in cardiovascular medicine 2020: acute coronary syndromes and intensive cardiac care. Eur Heart J. 2021 Mar 1;42(9):884-895. doi: 10.1093/eurheartj/ehaa1090.
- Park DW, Clare RM, Schulte PJ, Pieper KS, Shaw LK, Califf RM, Ohman EM, Van de Werf F, Hirji S, Harrington RA, Armstrong PW, Granger CB, Jeong MH, Patel MR. Extent, location, and clinical significance of non-infarct-related coronary artery disease among patients with ST-elevation myocardial infarction. JAMA. 2014 Nov 19;312(19):2019-27. doi: 10.1001/jama.2014.15095.
- Sorajja P, Gersh BJ, Cox DA, McLaughlin MG, Zimetbaum P, Costantini C, Stuckey T, Tcheng JE, Mehran R, Lansky AJ, Grines CL, Stone GW. Impact of multivessel disease on reperfusion success and clinical outcomes in patients undergoing primary percutaneous coronary intervention for acute myocardial infarction. Eur Heart J. 2007 Jul;28(14):1709-16. doi: 10.1093/eurheartj/ehm184. Epub 2007 Jun 7.
- Politi L, Sgura F, Rossi R, Monopoli D, Guerri E, Leuzzi C, Bursi F, Sangiorgi GM, Modena MG. A randomised trial of target-vessel versus multi-vessel revascularisation in ST-elevation myocardial infarction: major adverse cardiac events during long-term follow-up. Heart. 2010 May;96(9):662-7. doi: 10.1136/hrt.2009.177162. Epub 2009 Sep 23. Erratum In: Heart. 2014 Feb;100(4):350.
- Hannan EL, Samadashvili Z, Walford G, Holmes DR Jr, Jacobs AK, Stamato NJ, Venditti FJ, Sharma S, King SB 3rd. Culprit vessel percutaneous coronary intervention versus multivessel and staged percutaneous coronary intervention for ST-segment elevation myocardial infarction patients with multivessel disease. JACC Cardiovasc Interv. 2010 Jan;3(1):22-31. doi: 10.1016/j.jcin.2009.10.017.
- Montone RA, Niccoli G, Crea F, Jang IK. Management of non-culprit coronary plaques in patients with acute coronary syndrome. Eur Heart J. 2020 Oct 1;41(37):3579-3586. doi: 10.1093/eurheartj/ehaa481. Review.
- Wald DS, Morris JK, Wald NJ, Chase AJ, Edwards RJ, Hughes LO, Berry C, Oldroyd KG; PRAMI Investigators. Randomized trial of preventive angioplasty in myocardial infarction. N Engl J Med. 2013 Sep 19;369(12):1115-23. doi: 10.1056/NEJMoa1305520. Epub 2013 Sep 1.
- Gershlick AH, Khan JN, Kelly DJ, Greenwood JP, Sasikaran T, Curzen N, Blackman DJ, Dalby M, Fairbrother KL, Banya W, Wang D, Flather M, Hetherington SL, Kelion AD, Talwar S, Gunning M, Hall R, Swanton H, McCann GP. Randomized trial of complete versus lesion-only revascularization in patients undergoing primary percutaneous coronary intervention for STEMI and multivessel disease: the CvLPRIT trial. J Am Coll Cardiol. 2015 Mar 17;65(10):963-72. doi: 10.1016/j.jacc.2014.12.038.
- Engstrom T, Kelbaek H, Helqvist S, Hofsten DE, Klovgaard L, Holmvang L, Jorgensen E, Pedersen F, Saunamaki K, Clemmensen P, De Backer O, Ravkilde J, Tilsted HH, Villadsen AB, Aaroe J, Jensen SE, Raungaard B, Kober L; DANAMI-3-PRIMULTI Investigators. Complete revascularisation versus treatment of the culprit lesion only in patients with ST-segment elevation myocardial infarction and multivessel disease (DANAMI-3-PRIMULTI): an open-label, randomised controlled trial. Lancet. 2015 Aug 15;386(9994):665-71. doi: 10.1016/s0140-6736(15)60648-1.
- Smits PC, Abdel-Wahab M, Neumann FJ, Boxma-de Klerk BM, Lunde K, Schotborgh CE, Piroth Z, Horak D, Wlodarczak A, Ong PJ, Hambrecht R, Angeras O, Richardt G, Omerovic E; Compare-Acute Investigators. Fractional Flow Reserve-Guided Multivessel Angioplasty in Myocardial Infarction. N Engl J Med. 2017 Mar 30;376(13):1234-1244. doi: 10.1056/NEJMoa1701067. Epub 2017 Mar 18.
- Kornowski R, Mehran R, Dangas G, Nikolsky E, Assali A, Claessen BE, Gersh BJ, Wong SC, Witzenbichler B, Guagliumi G, Dudek D, Fahy M, Lansky AJ, Stone GW; HORIZONS-AMI Trial Investigators. Prognostic impact of staged versus "one-time" multivessel percutaneous intervention in acute myocardial infarction: analysis from the HORIZONS-AMI (harmonizing outcomes with revascularization and stents in acute myocardial infarction) trial. J Am Coll Cardiol. 2011 Aug 9;58(7):704-11. doi: 10.1016/j.jacc.2011.02.071.
- Manari A, Varani E, Guastaroba P, Menozzi M, Valgimigli M, Menozzi A, Magnavacchi P, Franco N, Marzocchi A, Casella G. Long-term outcome in patients with ST segment elevation myocardial infarction and multivessel disease treated with culprit-only, immediate, or staged multivessel percutaneous revascularization strategies: Insights from the REAL registry. Catheter Cardiovasc Interv. 2014 Nov 15;84(6):912-22. doi: 10.1002/ccd.25374. Epub 2014 Feb 1.
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
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2021-20
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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