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

1 april 2020 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Acute kransslagader syndroom

Gedetailleerde beschrijving

Henan institute of cardiology epidemiology is responsible for design, data quality control and statistical analysis.
Data were collected using a uniformed Case Report Form(CRF) by trained staff at each hospital.
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.
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.
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.

Studietype

Observationeel

Inschrijving (Werkelijk)

2014

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

China
- Henan
  - Zhengzhou, Henan, China, 450000
    - Henan Province People's Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

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

Beschrijving

Inclusion Criteria:

Age≥18 years.
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.
Informed consent signed by patients or legal guardians.

Exclusion Criteria:

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Major adverse cardiovascular and cerebrovascular events Tijdsspanne: 1 year	including all-caused death, nonfatal- myocardial infarction,and stroke	1 year

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Major adverse cardiovascular and cerebrovascular events Tijdsspanne: 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 Tijdsspanne: 6 month,1 year		6 month,1 year
Re-hospitalized Tijdsspanne: 6 month,1 year		6 month,1 year
Renal-Replaced therapy Tijdsspanne: 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) Tijdsspanne: At discharge(an average of 10 days),6 month,1 year		At discharge(an average of 10 days),6 month,1 year
Cardiogenic shock Tijdsspanne: At discharge(an average of 10 days)		At discharge(an average of 10 days)
New arrhythmia Tijdsspanne: At discharge(an average of 10 days)		At discharge(an average of 10 days)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Henan Institute of Cardiovascular Epidemiology

Onderzoekers

Hoofdonderzoeker: Chuanyu Gao, MD, Henan Institute of Cardiovascular Epidemiology

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 januari 2017

Primaire voltooiing (Werkelijk)

1 februari 2020

Studie voltooiing (Werkelijk)

1 maart 2020

Studieregistratiedata

Eerst ingediend

19 januari 2017

Eerst ingediend dat voldeed aan de QC-criteria

3 februari 2017

Eerst geplaatst (Schatting)

7 februari 2017

Updates van studierecords

Laatste update geplaatst (Werkelijk)

3 april 2020

Laatste update ingediend die voldeed aan QC-criteria

1 april 2020

Laatst geverifieerd