Clinical trial NCT02313038: Prospective Assessment of Efficacy and Safety of Drug Eluting Stents
Official title: Prospective Assessment of Efficacy and Safety of Drug Eluting Stents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Heart Disease
Keywords: Coronary heart disease
Percutaneous Coronary Intervention
Drug Eluting Stents
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2014-12-09
Enrollment: 6023
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent the first-ever DES deployment during the index hospitalization were consecutively recruited.

Brief summary: Coronary heart disease (CHD) pose a serious health threat to population. PCI using drug eluting stents (DES), as a well-proved and booming measure in CHD management, is invasive and of high cost, however the knowledge about the real-life DES use and the efficacy and safety in China is limited. By consecutively recruiting first-ever PCI patients in 30 geographically representative highest-rank hospitals, this study will examine the prognosis in groups with different brands of DES, and various real-life factors, that may affect patients recovery after the procedure. Evidence for clinical practice and health resource allocation will be established based on the findings, to improve patients outcomes in future finally.

Detailed description: In this study, 6000 patients who underwent the first-ever drug eluting stents (DES) deployment during the index hospitalization will be consecutively recruited in 30 tertiary hospitals scattered all over China. At study entry, participants will be interviewed during their index hospitalization, to collect information about symptoms, functioning, quality of life, and medical care. Demographic characteristics, medical history, clinical features, diagnostic tests, medications, procedures, and in-hospital outcomes of patients will be abstracted from medical records by well trained professional abstractors. And CAG imaging will be reviewed by national and international expert panels. At 1 month, 6 month, and 12 month after discharge, participants will return to the clinic for follow up visits, a face-to-face interview will be conducted to get information about clinical events, symptoms, functioning, quality of life, and medical care during the recovery period. At 1-Month and 12-Month follow-up visit, blood and urine sample will be collected. Participants' blood samples will be stored for future biologic and genetic studies. This study will examine the prognosis in groups with different brands of DES, and various real-life factors, that may affect patients recovery after the procedure. Evidence for clinical practice and health resource allocation will be established based on the findings, to improve patients outcomes in future finally.

Eligibility criteria: Inclusion Criteria:

* At least one DES is implanted successfully in the procedure
* Only one of the five major brands of DES is used in the procedure

Exclusion Criteria:

* Prior stent implantation history

Primary outcomes:
measure: Composite of major adverse cardiac events (MACE)
timeFrame: 1 year
Secondary outcomes:
measure: Safety endpoint
timeFrame: 1 year
measure: Efficacy composite endpoints
timeFrame: 1 year
measure: Status of general health
timeFrame: 1 year
measure: Quality of life
timeFrame: 1 year
measure: Symptoms status
timeFrame: 1 year
measure: Cost-effectiveness
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai hospital
state: Beijing
Study officials:
affiliation: China National Center for Cardiovascular Diseases
name: Lixin Jiang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Harlan M Krumholz, MD, SM
role: PRINCIPAL_INVESTIGATOR
References: