China PEACE-Prospective PCI Study

Coronary Heart Disease Clinical Trial

Official title:

The China PEACE (Patient-centered Evaluative Assessment of Cardiac Events) Prospective Study of Percutaneous Coronary Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01624922
• Other study ID #: WSGY-201202025-4
• Status: Completed
• Phase: N/A
• First received: June 17, 2012
• Last updated: August 27, 2015
• Start date: December 2012
• Est. completion date: July 2015

Study information

• Verified date: August 2015
• Source: China National Center for Cardiovascular Diseases
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Description:

Cardiovascular disease (CVD) is a major concern in public health globally, as well as in China, and remarkable variations of resources available and health system performance have been noted. Relatively limited information is available about how evidence-based therapies are incorporated appropriately into routine clinical practice. In addition, little information is available about the magnitude and quality of PCI, which has developed rapidly during the past several decades. Practical and applied knowledge from large unselected population is needed to guide practice and policy for quality improvement and cost reduction.

This study will enroll patients undergoing PCI after admission consecutively 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 various real-life factors that may affect patients recovery after PCI, including patients' characteristics and treatment measures. Practical guidelines, quality evaluative system, and appropriateness criteria will be established based on the findings, to improve patients outcomes in future finally.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5185
• Est. completion date: July 2015
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Previously enrolled in the PEACE study

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
China	Fuwai Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases	Ministry of Health, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cognitive function (MMSE)		1 year	No
Other	Sexual activity/function		1 year	No
Primary	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	Yes
Secondary	Symptoms status (SAQ)		1 year	Yes
Secondary	Quality of life (EQ-5D)		1 year	Yes
Secondary	Depression (PHQ-8)		1 year	Yes
Secondary	Stress (PSS-4)		1 year	Yes
Secondary	Cardiac death		1 year	Yes
Secondary	Fatal or non-fatal AMI		1 year	Yes
Secondary	Coronary revascularization procedure		1 year	Yes
Secondary	Ischemic stroke		1 year	Yes
Secondary	Re-admission		1 year	Yes
Secondary	Adherence to medications for secondary prevention	Taking the following medications for 6 or more days per week: aspirin, clopidogrel, ACEI/ARB, statin and beta-blockers	1 year	No
Secondary	Control of risk factors	Control of hypertension, diabetes, dyslipidemia, smoking, and obesity	1 year	No