NCT03051048

Brief Summary

Acute myocardial infarction (AMI) pose a pool clinical outcome to men and women whom treatment was delayed. However, reperfusion time was limited in previous studies. To evaluate the system delay and clinical outcomes among Chinese patients with AMI, consecutive inpatient case prospectively collected from 1999 to 2016. Basic data and innovative evidence will accelerate evidence-based clinical practice and policy making, and improve AMI patients outcomes finally.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 1999

Longer than P75 for all trials

Geographic Reach
1 country

23 active sites

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

Study Start

First participant enrolled

January 1, 1999

Completed
18.1 years until next milestone

First Submitted

Initial submission to the registry

February 9, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 13, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
Last Updated

December 6, 2017

Status Verified

December 1, 2017

Enrollment Period

18.5 years

First QC Date

February 9, 2017

Last Update Submit

December 5, 2017

Conditions

Keywords

Acute Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • 30-Day Freedom From Mortality

    All-cause death

    30 days

Secondary Outcomes (4)

  • 12-Month Freedom From Major Adverse Cardiac Events (MACE)

    12 months

  • Cardiac death

    12 months

  • Myocardial infarction

    12 months

  • Target vessel revascularization

    12 months

Study Arms (2)

Group 1

The patient received reperfusion therapy between 1999 January 1 and 2009 December 31

Procedure: Reperfusion

Group 2

The patient received reperfusion therapy between 2010 January 1 and 2016 December 31

Procedure: Reperfusion

Interventions

ReperfusionPROCEDURE
Group 1Group 2

Eligibility Criteria

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

In China, 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 similar study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Changshu First People's Hospital

Changshu, Jiangsu, China

Location

Changzhou Traditional Chinese Medicine Hospital

Changzhou, Jiangsu, China

Location

Jintan People's Hospital

Jintan, Jiangsu, China

Location

Liyang Hospital of TCM

Liyang, Jiangsu, China

Location

Gaochun People's Hospital

Nanjing, Jiangsu, China

Location

Anqing First People's Hospital

Anqing, China

Location

The 123 Hospital of PLA

Bengbu, China

Location

Changzhou Fouth People's Hospital

Changzhou, China

Location

Huaian Second People's Hospital

Huai'an, China

Location

Huainan Eastern Hospital

Huainan, China

Location

Huainan Xinhua Hospital

Huainan, China

Location

Maanshan Shiqiye Hospital

Ma’anshan, China

Location

Muyang Traditional Chinese Medicine Hospital

Muyang, China

Location

Nanjing First Hospital

Nanjing, China

Location

Nanjing Pukou Central Hospital

Nanjing, China

Location

Nnajing 81 Hospital

Nanjing, China

Location

Nnajing Integrated Traditional Chinese and Westem Medicine Hospital

Nanjing, China

Location

Taicang First People's Hospital

Taicang, China

Location

Wuxi Third Hospital

Wuxi, China

Location

Yixin People's Hospital

Wuxi, China

Location

Yixing Traditional Chinese Medicine Hospital

Wuxi, China

Location

Xuncheng Central Hospital

Xuancheng, China

Location

Zhangjiagang First People's Hospital

Zhangjiagang, China

Location

Related Publications (1)

  • Xue X, Kan J, Zhang JJ, Tian N, Ye F, Yang S, Qu H, Chen SL; MOODY trial investigators. Comparison in Prevalence, Predictors, and Clinical Outcome of VSR Versus FWR after Acute Myocardial Infarction: The Prospective, Multicenter Registry MOODY Trial-Heart Rupture Analysis. Cardiovasc Revasc Med. 2019 Dec;20(12):1158-1164. doi: 10.1016/j.carrev.2019.01.023. Epub 2019 Jan 23.

MeSH Terms

Conditions

Coronary Disease

Interventions

Reperfusion

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical ProceduresSurgical Procedures, OperativePerfusionInvestigative Techniques

Study Officials

  • Shaoliang Chen, PhD

    Nanjing First Hospital, Nanjing Medical University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice President

Study Record Dates

First Submitted

February 9, 2017

First Posted

February 13, 2017

Study Start

January 1, 1999

Primary Completion

June 30, 2017

Study Completion

September 30, 2017

Last Updated

December 6, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations