Prospective Evaluation of Prognosis of Pci Patients Using Network Data in SHengjing Hospital

NCT02667548 | Unknown

• 1 other identifier: 2016PS04K02
• Study Type: observational
• Target: 7,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

Coronary heart disease (CHD) has a serious health threaten to population. PCI is a well-proved measure in CHD management. However, the knowledge about the real-life PCI use and how evidence-based therapies in routine clinical practice is limited. By consecutively recruiting PCI patients in a large-scale hospital in in Northeast China,this study will examine various real-life factors, that may affect patients recovery after the procedure. Practical guidelines, appropriateness criteria and quality evaluative system for PCI will be established based on the findings, to improve patients outcomes in future finally.

Conditions

Coronary Heart Disease

Keywords

percutaneous coronary intervention

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants with Major adverse cardiovascular events (MACE)

  Composite of major adverse cardiovascular events (MACE) including cardiac death, non-fatal AMI, coronary revascularization procedure, or ischemic stroke

  5 year

Secondary Outcomes (12)

• Percentage of Participants with all-cause death

  5 year

• Percentage of Participants with cardiac death

  5 year

• Percentage of Participants with non-fatal AMI

  5 year

• Percentage of Participants with coronary revascularization procedure

  5 year

• Percentage of Participants with ischemic stroke

  5 year

Other Outcomes (2)

• Cognitive function as assessed by MMSE

  5 year

• Sexual activity as assessed by a question: Have participants had sex or sexual activity since participants were hospitalized for heart attack or heart problem? Response Options:Dichotomous (Y/N)

  5 year

Study Arms (1)

patients receiving PCI

patients receiving PCI

Procedure: PCI

Interventions

PCI PROCEDURE

percutaneous coronary intervention

patients receiving PCI

Eligibility Criteria

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

Study Population

In department of Cardiology,Shengjing Hospital of China Medical University, 7000 hospitalized patients undergoing Percutaneous Coronary Intervention will be enrolled consecutively.

You may qualify if:

• Hospitalized patients undergoing a percutaneous coronary intervention (PCI) for coronary lesions.

You may not qualify if:

• Previously enrolled in the R-PUSH study

Sponsors & Collaborators

• Shengjing Hospital: lead

Biospecimen

Retention: SAMPLES WITH DNA

A venous blood sample of 10mL will be collected before discharge for biomarker analysis and storage for future genetic studies.

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Tongtong Yu, Doctor

  Shengjing Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: attending physician

Study Record Dates

• First Submitted: January 21, 2016
• First Posted: January 29, 2016
• Study Start: January 1, 2016
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: March 6, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share