- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07557238
Et multicenter-registreringsstudie af patienter med kompleks højrisiko PCI (CHIP-CC)
Et multicenter registerstudie af komplekse højrisiko-PCI-patienter (CHIP-PCI registret)
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Guofeng Gao, MD
- Telefonnummer: +86-13811458815
- E-mail: ggf03@163.com
Studiesteder
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Beijing, Kina, 100037
- Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
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Kontakt:
- Guofeng Gao, MD
- Telefonnummer: +86-13811458815
- E-mail: ggf03@163.com
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inklusionskriterier:<\/p>
18 \u00e5r \u2264 patient \u2264 90 \u00e5r;
- Patienten er villig til at overholde forskningsprotokollens krav og dataindsamlingsprocedurer, forst\u00e5 forskningsm\u00e5lene og underskrive en informeret samtykkeerkl\u00e6ring; \u2462 Hjerteteamet har fastsl\u00e5et, at patienten har indikationer for koronar revaskularisering, men risikoen for CABG er h\u00f8j, eller patienten n\u00e6gter at gennemg\u00e5 CABG. Efter evaluering mener hjerteteamet, at PCI kan gavne patienten; \u2463 Venstre ventrikels ejektionsfraktion (LVEF) \u2264 35%, eller LVEF \u2264 40% med svær mitralregurgitation \u2464 Kompleks PCI opfylder en af f\u00f8lgende betingelser: a) Ubeskyttet venstre hovedstammel\u00e6sion b) Den sidste \u00e5bne koronar PCI c) Trel\u00e6sionssygdom (koronar angiografi viser samtidig stenose af den forreste descendens, circumflex og h\u00f8jre koronararterie med en stenosegrad >70%) d) Forkalkede l\u00e6sioner kr\u00e6ver koronar plaque rotationsaterektomi e) CTO-l\u00e6sioner kr\u00e6ver bilateral kontrastafbildning eller omvendt teknologi
\/
\/li><\/ul><\/li><\/ul>Eksklusionskriterier:<\/p>
Akut ST-segment elevationsinfarkt inden for en uge;
Kombineret kardiogent shock (kardiogent shock er defineret som samtidig opfyldelse af f\u00f8lgende tre betingelser: \u2460 arterielt systolisk tryk<90mmHg i \u2265 30 minutter, eller behov for st\u00f8tte fra vasopressorer\/inotrope l\u00e6gemidler\/mekanisk cirkulation for at opretholde arterielt systolisk tryk \u2265 90mmHg; \u2461 Der er tegn p\u00e5 reduceret hjertevolumen, s\u00e5som et hjerteindeks<2.2L\/min\/m2;
\u2462 Der foreligger et f\u00e6nomen med organhypoperfusion, herunder et fald i hudtemperaturen p\u00e5 ekstremiteterne, et fald i urinproduktionen<30ml\/h, bevidsthedsforstyrrelser eller en stigning i laktat>2mmol\/L);- Patienten er ude af stand til at gennemf\u00f8re den efterf\u00f8lgende opf\u00f8lgning; \u2463 Andre situationer, som forskerne mener ikke er egnede til inklusion<\/li><\/ul><\/li><\/ul><\/li><\/ul>
- Patienten er villig til at overholde forskningsprotokollens krav og dataindsamlingsprocedurer, forst\u00e5 forskningsm\u00e5lene og underskrive en informeret samtykkeerkl\u00e6ring; \u2462 Hjerteteamet har fastsl\u00e5et, at patienten har indikationer for koronar revaskularisering, men risikoen for CABG er h\u00f8j, eller patienten n\u00e6gter at gennemg\u00e5 CABG. Efter evaluering mener hjerteteamet, at PCI kan gavne patienten; \u2463 Venstre ventrikels ejektionsfraktion (LVEF) \u2264 35%, eller LVEF \u2264 40% med svær mitralregurgitation \u2464 Kompleks PCI opfylder en af f\u00f8lgende betingelser: a) Ubeskyttet venstre hovedstammel\u00e6sion b) Den sidste \u00e5bne koronar PCI c) Trel\u00e6sionssygdom (koronar angiografi viser samtidig stenose af den forreste descendens, circumflex og h\u00f8jre koronararterie med en stenosegrad >70%) d) Forkalkede l\u00e6sioner kr\u00e6ver koronar plaque rotationsaterektomi e) CTO-l\u00e6sioner kr\u00e6ver bilateral kontrastafbildning eller omvendt teknologi
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
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CHIP-PCI Registry Cohort
Patients with complex high-risk indicated coronary artery disease undergoing percutaneous coronary intervention as part of routine clinical practice.
Eligible patients include adults with complex coronary anatomy and reduced left ventricular function who are considered by the heart team to have an indication for coronary revascularization but are at high risk for coronary artery bypass grafting or decline surgical revascularization.
PCI strategy, use of intravascular imaging or physiological assessment, revascularization approach, antithrombotic therapy, and use of mechanical circulatory support are determined by the treating physicians according to clinical judgment and local practice.
No study-mandated intervention is assigned.
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Percutaneous coronary intervention performed as part of routine clinical care in patients with complex high-risk indicated coronary artery disease.
The procedural strategy, use of intravascular imaging or physiological assessment, lesion preparation, revascularization extent, staged PCI, antithrombotic therapy, and use of mechanical circulatory support are determined by the treating physicians according to clinical judgment and local practice.
No study-mandated intervention is assigned.
Andre navne:
Mechanical circulatory support, including intra-aortic balloon pump, extracorporeal membrane oxygenation, Impella-like devices, or other support devices, may be used during high-risk PCI at the discretion of the treating physicians.
Use of mechanical circulatory support is not mandated by the study protocol and will be analyzed as an observational exposure.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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All-cause Mortality at 1 Year After PCI
Tidsramme: 1 year after PCI
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The proportion of participants who die from any cause within 1 year after percutaneous coronary intervention.
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1 year after PCI
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Major Adverse Cardiovascular Events at 1 Year After PCI
Tidsramme: 1 year after PCI
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The proportion of participants who experience a major adverse cardiovascular event within 1 year after PCI.
Major adverse cardiovascular events are defined as a composite of all-cause death, myocardial infarction, target vessel revascularization, or hospitalization for heart failure.
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1 year after PCI
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Cardiac death at 1 year after PCI
Tidsramme: 1 year after PCI
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The proportion of participants who die from cardiac causes within 1 year after PCI.
Cardiac death includes death due to acute myocardial infarction, heart failure, cardiogenic shock, pulmonary edema, cardiac perforation or tamponade, arrhythmia or conduction disturbance, procedure-related cerebrovascular events within 30 days, procedure-related complications, or death in which a cardiac cause cannot be excluded.
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1 year after PCI
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Myocardial Infarction at 1 Year After PCI
Tidsramme: 1 year after PCI
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The proportion of participants who experience myocardial infarction within 1 year after PCI, including peri-procedural myocardial infarction and spontaneous myocardial infarction according to predefined study criteria.
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1 year after PCI
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Target Vessel Revascularization at 1 Year After PCI
Tidsramme: 1 year after PCI
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The proportion of participants who undergo repeat revascularization of the target vessel within 1 year after PCI.
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1 year after PCI
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Hospitalization for Heart Failure at 1 Year After PCI
Tidsramme: 1 year after PCI
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The proportion of participants hospitalized for worsening heart failure within 1 year after PCI.
Heart failure hospitalization is defined as hospitalization lasting at least 24 hours due to worsening heart failure symptoms, with a documented diagnosis of heart failure and initiation or intensification of heart failure therapy.
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1 year after PCI
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Major Bleeding at 1 Year After PCI
Tidsramme: 1 year after PCI
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The proportion of participants who experience major bleeding within 1 year after PCI.
Major bleeding is defined as Bleeding Academic Research Consortium type 3 or type 5 bleeding.
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1 year after PCI
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Change in Health-Related Quality of Life Assessed by EQ-5D-5L
Tidsramme: Baseline, 3 months, 6 months, 1 year, and 2 years after PCI
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Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level questionnaire.
Scores will be collected at baseline and during follow-up to evaluate changes after PCI.
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Baseline, 3 months, 6 months, 1 year, and 2 years after PCI
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Change in Angina-Related Quality of Life Assessed by the Seattle Angina Questionnaire
Tidsramme: Baseline, 3 months, 6 months, 1 year, and 2 years after PCI
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Angina-related symptoms, functional status, and quality of life will be assessed using the Seattle Angina Questionnaire.
Scores will be collected at baseline and during follow-up to evaluate changes after PCI.
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Baseline, 3 months, 6 months, 1 year, and 2 years after PCI
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Karsygdomme
- Hjerte-kar-sygdomme
- Hjertesygdomme
- Ventrikulær dysfunktion
- Åreforkalkning
- Arterielle okklusive sygdomme
- Koronar sygdom
- Myokardieiskæmi
- Ventrikulær dysfunktion, venstre
- Koronararteriesygdom
- Kirurgiske procedurer, operative
- Endovaskulære procedurer
- Vaskulære kirurgiske procedurer
- Kardiovaskulære kirurgiske procedurer
- Minimalt invasive kirurgiske procedurer
- Perkutan koronar intervention
Andre undersøgelses-id-numre
- 2026-3151
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
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