NCT01624909

Brief Summary

Coronary heart disease (CHD) and heart attacks pose a serious health risk to men and women, however little information is available about how evidence-based therapies are incorporated appropriately into routine clinical practice in China. In addition, basic data and evidence about safety and efficacy of treatment for AMI is limited. By consecutively recruiting AMI patients in 40 hospitals of different levels, this study will examine various real-life factors, that may affect patients recovery after a heart attack. Practical guidelines and risk model for AMI patients will be established based on the findings, to improve patients outcomes in future finally.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,286

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 21, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

August 31, 2015

Status Verified

August 1, 2015

Enrollment Period

1.4 years

First QC Date

June 17, 2012

Last Update Submit

August 27, 2015

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

  • +6 more secondary outcomes

Other Outcomes (2)

  • Cognitive function (MMSE)

    1 year

  • Sexual activity/function

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

In 40 hospitals of different levels in China, 4000 hospitalized patients with acute myocardial infarction will be enrolled consecutively.

You may qualify if:

  • Hospitalized patients with acute myocardial infarction according to positive cardiac biomarkers (Troponin I/T, CK-MB or CK≥ local laboratory upper limit of normal values within 24 hours after initial presentation, and at least one of the following two supporting evidence of ischemia (ischemic symptoms occurring within 24 hours before admission or up to 72 hours for STEMI; ECG changes indicative of new ischemia).

You may not qualify if:

  • Previously enrolled in the PEACE study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuwai Hospital

Beijing, Beijing Municipality, 100037, China

Location

Related Publications (6)

  • Li J, Dharmarajan K, Bai X, Masoudi FA, Spertus JA, Li X, Zheng X, Zhang H, Yan X, Dreyer RP, Krumholz HM. Thirty-Day Hospital Readmission After Acute Myocardial Infarction in China. Circ Cardiovasc Qual Outcomes. 2019 May;12(5):e005628. doi: 10.1161/CIRCOUTCOMES.119.005628.

    PMID: 31092023DERIVED

  • Shang P, Liu GG, Zheng X, Ho PM, Hu S, Li J, Jiang Z, Li X, Bai X, Gao Y, Xing C, Wang Y, Normand SL, Krumholz HM. Association Between Medication Adherence and 1-Year Major Cardiovascular Adverse Events After Acute Myocardial Infarction in China. J Am Heart Assoc. 2019 May 7;8(9):e011793. doi: 10.1161/JAHA.118.011793.

    PMID: 31057004DERIVED

  • Huo X, Khera R, Zhang L, Herrin J, Bai X, Wang Q, Lu Y, Nasir K, Hu S, Li J, Li X, Zheng X, Masoudi FA, Spertus JA, Krumholz HM, Jiang L. Education level and outcomes after acute myocardial infarction in China. Heart. 2019 Jun;105(12):946-952. doi: 10.1136/heartjnl-2018-313752. Epub 2019 Jan 19.

    PMID: 30661037DERIVED

  • Jiang Z, Dreyer RP, Spertus JA, Masoudi FA, Li J, Zheng X, Li X, Wu C, Bai X, Hu S, Wang Y, Krumholz HM, Chen H; China Patient-centered Evaluative Assessment of Cardiac Events (PEACE) Collaborative Group. Factors Associated With Return to Work After Acute Myocardial Infarction in China. JAMA Netw Open. 2018 Nov 2;1(7):e184831. doi: 10.1001/jamanetworkopen.2018.4831.

    PMID: 30646375DERIVED

  • Guan W, Venkatesh AK, Bai X, Xuan S, Li J, Li X, Zhang H, Zheng X, Masoudi FA, Spertus JA, Krumholz HM, Jiang L. Time to hospital arrival among patients with acute myocardial infarction in China: a report from China PEACE prospective study. Eur Heart J Qual Care Clin Outcomes. 2019 Jan 1;5(1):63-71. doi: 10.1093/ehjqcco/qcy022.

    PMID: 29878087DERIVED

  • Qi Y, Wang W, Zhang K, An S, Wang S, Zheng J, Tang YD. Development and validation of Women Acute Myocardial Infarction in-Hospital Mortality Score (WAMI Score). Int J Cardiol. 2018 May 15;259:31-39. doi: 10.1016/j.ijcard.2017.12.010.

    PMID: 29579607DERIVED

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 IschemiaHeart DiseasesCardiovascular DiseasesVascular 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

May 1, 2014

Study Completion

July 1, 2015

Last Updated

August 31, 2015

Record last verified: 2015-08

Locations

CN(1)