China PEACE-Prospective PCI Study

NCT01624922 | Completed DMC

• 1 other identifier: WSGY-201202025-4
• Study Type: observational
• Target: 5,185
• Locations: 1 country
• Sites: 1

Brief Summary

Coronary heart disease (CHD) pose a serious health threaten to population. PCI, as a well-proved and booming measure in CHD management, is invasive and of high cost, however the knowledge about the real-life PCI use in China is limited. By consecutively recruiting PCI patients in 30 geographically representative highest-rank hospitals, 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

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiovascular events (MACE)

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

  1 year

Secondary Outcomes (11)

• Symptoms status (SAQ)

  1 year

• Quality of life (EQ-5D)

  1 year

• Depression (PHQ-8)

  1 year

• Stress (PSS-4)

  1 year

• Cardiac death

  1 year

Other Outcomes (2)

• Cognitive function (MMSE)

  1 year

• Sexual activity/function

  1 year

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 30 tertiary hospitals with capability of Percutaneous Coronary Intervention in China, 3000 hospitalized patients undergoing Percutaneous Coronary Intervention will be enrolled consecutively.

You may qualify if:

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

You may not qualify if:

• Previously enrolled in the PEACE study

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead
• Ministry of Health, China: collaborator

Study Sites (1)

Fuwai Hospital

Beijing, Beijing Municipality, 100037, China

Location

Related Publications (1)

• Zheng X, Dreyer RP, Curtis JP, Liu S, Xu X, Bai X, Li X, Zhang H, Wang S, Masoudi FA, Spertus JA, Li J, Krumholz HM; China PEACE Collaborative Group. Sex Differences in 1-Year Health Status Following Percutaneous Coronary Intervention in Patients Without Acute Myocardial Infarction: Results From the China PEACE Prospective Study. J Am Heart Assoc. 2020 Mar 17;9(6):e014421. doi: 10.1161/JAHA.119.014421. Epub 2020 Mar 5.

  PMID: 32131687 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

A venous blood sample of 20mL will be collected at 1-month visit and 12-month visit for biomarker analysis and storage for future genetic studies; A urine samples of 40mL will be collected at 1-month visit and 12-month visit for biomarker analysis and storage.

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Lixin Jiang, M.D., Ph.D.

  China National Center for Cardiovascular Diseases

  PRINCIPAL INVESTIGATOR

• Harlan M Krumholz, M.D., S.M.

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 17, 2012
• First Posted: June 21, 2012
• Study Start: December 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: July 1, 2015
• Last Updated: August 31, 2015

Record last verified: 2015-08

Locations

CN (1)