System Delay and Clinical Outcome Among Chinese Patients With AMI Treated With Reperfusion Therapy (MOODY Study) (MOODY)

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.

Study Overview

• Status: Completed
• Conditions: Coronary Heart Disease
• Intervention / Treatment: Procedure: Reperfusion

Detailed Description

AMI is one of the leading causes of mortality and morbidity in public health globally, as well as in China. Remarkable variations of repercussion time and clinical outcome have been noted, however little information is available about how shortened D2B time is incorporated appropriately into routine clinical practice in China. In addition, basic data and evidence about effectiveness of treatment for AMI during long-term recovery is limited. Practical and applied knowledge from large unselected population is needed to guide practice for improvement.

This study will enroll patients with a confirmed diagnosis of AMI consecutively in 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. At 1 month, and 12 month after discharge, participants will return to the clinic for follow up visits. This study will examine system delay that may affect patients recovery after a heart attack. Effective clinic path system, and risk model for AMI patients will be established based on the findings, to improve patients outcomes in future finally.

• Study Type: Observational
• Enrollment (Actual): 8000

Contacts and Locations

Study Locations

• China
  • Anqing, China
    • Anqing First People's Hospital
  • Bengbu, China
    • The 123 Hospital of PLA
  • Changzhou, China
    • Changzhou Fouth People's Hospital
  • Huai'an, China
    • Huaian Second People's Hospital
  • Huainan, China
    • Huainan Eastern Hospital
  • Huainan, China
    • Huainan Xinhua Hospital
  • Ma'anshan, China
    • Maanshan Shiqiye Hospital
  • Muyang, China
    • Muyang Traditional Chinese Medicine Hospital
  • Nanjing, China
    • Nanjing First Hospital
  • Nanjing, China
    • Nanjing Pukou Central Hospital
  • Nanjing, China
    • Nnajing 81 Hospital
  • Nanjing, China
    • Nnajing Integrated Traditional Chinese and Westem Medicine Hospital
  • Taicang, China
    • Taicang First People's Hospital
  • Wuxi, China
    • Wuxi Third Hospital
  • Wuxi, China
    • Yixin People's Hospital
  • Wuxi, China
    • Yixing Traditional Chinese Medicine Hospital
  • Xuancheng, China
    • Xuncheng Central Hospital
  • Zhangjiagang, China
    • Zhangjiagang First People's Hospital
  • Jiangsu
    • Changshu, Jiangsu, China
      • Changshu first people's Hospital
    • Changzhou, Jiangsu, China
      • Changzhou Traditional Chinese Medicine Hospital
    • Jintan, Jiangsu, China
      • Jintan People's Hospital
    • Liyang, Jiangsu, China
      • Liyang Hospital of TCM
    • Nanjing, Jiangsu, China
      • Gaochun People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

In China, hospitalized patients with acute myocardial infarction will be enrolled consecutively.

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• Previously enrolled in the similar study

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-Day Freedom From Mortality	All-cause death	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
12-Month Freedom From Major Adverse Cardiac Events (MACE)	Composite of MACE including cardiac death, non-fatal AMI, and clinically driven target vessel revascularization.	12 months
Cardiac death	Death that could not be attributed to a noncardiac etiology was considered cardiac death.	12 months
Myocardial infarction	Myocardial infarction was diagnosed by electrocardiographic changes and/or a rise and fall of creatine kinase-myocardial band fraction in the presence of ischemic symptoms.	12 months
Target vessel revascularization	Target vessel revascularization was defined as repeated revascularization by PCI or surgery of the target vessel.	12 months

Collaborators and Investigators

• Sponsor: Nanjing First Hospital, Nanjing Medical University
• Investigators: Study Chair: Shaoliang Chen, phd, Nanjing First Hospital, Nanjing Medical University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 1999
• Primary Completion (Actual): June 30, 2017
• Study Completion (Actual): September 30, 2017

Study Registration Dates

• First Submitted: February 9, 2017
• First Submitted That Met QC Criteria: February 9, 2017
• First Posted (Actual): February 13, 2017

Study Record Updates

• Last Update Posted (Actual): December 6, 2017
• Last Update Submitted That Met QC Criteria: December 5, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Acute Myocardial Infarction
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: NFH20170208

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No