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

Acute Coronary Syndrome Clinical Trial

— PACS-RI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03044990
• Other study ID #: HenanICE201603
• Status: Completed
• Start date: January 2017
• Est. completion date: March 1, 2020

Study information

• Verified date: April 2020
• Source: Henan Institute of Cardiovascular Epidemiology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2014
• Est. completion date: March 1, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Renal Insufficiency
• Syndrome

Locations

Country	Name	City	State
China	Henan province people's hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Henan Institute of Cardiovascular Epidemiology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiovascular and cerebrovascular events	including all-caused death, nonfatal- myocardial infarction,and stroke	1 year
Secondary	Major adverse cardiovascular and cerebrovascular events	including all-caused death, nonfatal- myocardial infarction,and stroke	At discharge(an average of 10 days),6 month
Secondary	Coronary revascularization		6 month,1 year
Secondary	Re-hospitalized		6 month,1 year
Secondary	Renal-Replaced therapy		At discharge(an average of 10 days),6 month,1 year
Secondary	Bleeding according to GUSTO bleeding grade(excluding hemorrhage stroke)		At discharge(an average of 10 days),6 month,1 year
Secondary	Cardiogenic shock		At discharge(an average of 10 days)
Secondary	New arrhythmia		At discharge(an average of 10 days)