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

NCT03044990 | Completed DMC

• 1 other identifier: HenanICE201603
• Study Type: observational
• Target: 2,014
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Coronary Syndrome

Keywords

Acute coronary syndrome; renal insufficiency; mortality

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiovascular and cerebrovascular events

  including all-caused death, nonfatal- myocardial infarction,and stroke

  1 year

Secondary Outcomes (7)

• Major adverse cardiovascular and cerebrovascular events

  At discharge(an average of 10 days),6 month

• Coronary revascularization

  6 month,1 year

• Re-hospitalized

  6 month,1 year

• Renal-Replaced therapy

  At discharge(an average of 10 days),6 month,1 year

• Bleeding according to GUSTO bleeding grade(excluding hemorrhage stroke)

  At discharge(an average of 10 days),6 month,1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henan Institute of Cardiovascular Epidemiology: lead

Study Sites (1)

Henan province people's hospital

Zhengzhou, Henan, 450000, China

Location

MeSH Terms

Conditions

Acute Coronary Syndrome; Renal Insufficiency

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Chuanyu Gao, MD

  Henan Institute of Cardiovascular Epidemiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2017
• First Posted: February 7, 2017
• Study Start: January 1, 2017
• Primary Completion: February 1, 2020
• Study Completion: March 1, 2020
• Last Updated: April 3, 2020

Record last verified: 2020-04

Locations

CN (1)