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Prognosis of Patients With Acute Coronary Syndrome Complicated With Renal Insufficiency(PACS-RI) (PACS-RI)

1. april 2020 opdateret af: Henan Institute of Cardiovascular Epidemiology

Study on the Prognosis of Patients With Acute Coronary Syndrome Complicated With Renal Insufficiency: a Prospective, Multicenter, Observational Study

Several epidemiologic studies reported that patients with renal insufficiency might have increased cardiovascular disease-related mortality rates after Percutaneous coronary intervention (PCI) . The increased risk in this population may be related to the less use of standard guideline-based treatment and the resulting inability to perform PCI effectively. Recently, with the technology improvement and the progress in clinical trials, Chinese guidelines have made new recommendations about the patients with acute coronary syndrome(ACS) in different states of renal function. However, scant epidemiologic information exists on the prognosis of those patients, especially in Henan. And there is still some uncertainty whether those patients are using the latest guideline recommended treatment.

This multicenter, prospective, observational study is aimed to evaluate the long prognosis in patients with acute coronary syndrome complicated with renal insufficiency, and to analysis its related factors that influence the outcomes.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

  1. Henan institute of cardiology epidemiology is responsible for design, data quality control and statistical analysis.
  2. Data were collected using a uniformed Case Report Form(CRF) by trained staff at each hospital.
  3. Sample size estimation: Based on retrospective observational cohort of ACS patients, 1-year mortality in normal renal function and renal disfunction were 2.8% and 7.9%, respectively. To achieve a precision of 15% with an α of 0.05, the loss ratio of following-up is 10%.The investigators would need a sample of 2000.
  4. Statistical analysis plan: the investigators will report summary statistics for patient characteristics, renal function status, comorbidities, treatment strategies and outcomes. the investigators will also undertake the following prespecified subgroup analyses: age, sex, STE-ACS or NSTE-ACS, history of diabetes, history of hypertension, smoking and Syntax score.
  5. Quality assurance plan 1)Diagnosis of ACS is according to the third universal definition.2)Before registry, a training program on study objectives, data collection, and ACS management is given to the primary investigator and related staff at each participating center.3)Henan institute of cardiology epidemiology will regularly monitored at least 10% of CRFs for accuracy against medical records. If the CRFs are not completed with 98% accuracy, all CRFs are considered unqualified and this staff will be retrained.4)Before entering into the computer, data is queried for invalid and illogical values by research staff in Henan institute of cardiology epidemiology. Participating centres who has the high error rate of data, and no change in 6 months shall be deemed abandoned automatically; participating centres who has the high quality of data will be issued a certificate to reward.5)Investigator meeting will be annually held to conclude the progress, solve existing problems and strengthen program training.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

2014

Kontakter og lokationer

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

Studiesteder

  • Kina
    • Henan
      • Zhengzhou, Henan, Kina, 450000
        • Henan Province People's Hospital

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

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

7 eligible sites in Henan province will participate. Each site will enroll patients who meet the inclusion criteria consecutively.

Beskrivelse

Inclusion Criteria:

  1. Age≥18 years.
  2. Patients with clinical evidence of acute coronary syndrome, including ST segment elevation myocardial infarction (STEMI), non ST segment elevation myocardial infarction (NSTEMI) and unstable angina.
  3. Informed consent signed by patients or legal guardians.

Exclusion Criteria:

  1. Non-atherosclerotic coronary heart disease
  2. Organ failure other than heart failure and kidney failure
  3. Considered not fit for the study due to other reasons, including but not restricted to : a. Severe infection; b. cachexia;c.maintenance hemodialysis.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Major adverse cardiovascular and cerebrovascular events
Tidsramme: 1 year
including all-caused death, nonfatal- myocardial infarction,and stroke
1 year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Major adverse cardiovascular and cerebrovascular events
Tidsramme: At discharge(an average of 10 days),6 month
including all-caused death, nonfatal- myocardial infarction,and stroke
At discharge(an average of 10 days),6 month
Coronary revascularization
Tidsramme: 6 month,1 year
6 month,1 year
Re-hospitalized
Tidsramme: 6 month,1 year
6 month,1 year
Renal-Replaced therapy
Tidsramme: At discharge(an average of 10 days),6 month,1 year
At discharge(an average of 10 days),6 month,1 year
Bleeding according to GUSTO bleeding grade(excluding hemorrhage stroke)
Tidsramme: At discharge(an average of 10 days),6 month,1 year
At discharge(an average of 10 days),6 month,1 year
Cardiogenic shock
Tidsramme: At discharge(an average of 10 days)
At discharge(an average of 10 days)
New arrhythmia
Tidsramme: At discharge(an average of 10 days)
At discharge(an average of 10 days)

Samarbejdspartnere og efterforskere

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

Sponsor

Henan Institute of Cardiovascular Epidemiology

Efterforskere

  • Ledende efterforsker: Chuanyu Gao, MD, Henan Institute of Cardiovascular Epidemiology

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 (Faktiske)

1. januar 2017

Primær færdiggørelse (Faktiske)

1. februar 2020

Studieafslutning (Faktiske)

1. marts 2020

Datoer for studieregistrering

Først indsendt

19. januar 2017

Først indsendt, der opfyldte QC-kriterier

3. februar 2017

Først opslået (Skøn)

7. februar 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. april 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. april 2020

Sidst verificeret

1. april 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HenanICE201603

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 .

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