Clinical trial NCT03051048: System Delay and Clinical Outcome Among Chinese Patients With AMI Treated With Reperfusion Therapy (MOODY Study)
Official title: System Delay and Clinical Outcome Among Chinese Patients With AMI Treated With Reperfusion Therapy (MOODY Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Heart Disease
Keywords: Acute Myocardial Infarction
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2017-02-13
Enrollment: 8000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In China, hospitalized patients with acute myocardial infarction will be enrolled consecutively.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 30-Day Freedom From Mortality
timeFrame: 30 days
Secondary outcomes:
measure: 12-Month Freedom From Major Adverse Cardiac Events (MACE)
timeFrame: 12 months
measure: Cardiac death
timeFrame: 12 months
measure: Myocardial infarction
timeFrame: 12 months
measure: Target vessel revascularization
timeFrame: 12 months
Other outcomes:
Locations:
city: Changshu
country: China
facility: Changshu First People's Hospital
state: Jiangsu
city: Changzhou
country: China
facility: Changzhou Traditional Chinese Medicine Hospital
state: Jiangsu
city: Jintan
country: China
facility: Jintan People's Hospital
state: Jiangsu
city: Liyang
country: China
facility: Liyang Hospital of TCM
state: Jiangsu
city: Nanjing
country: China
facility: Gaochun People's Hospital
state: Jiangsu
city: Anqing
country: China
facility: Anqing First People's Hospital
city: Bengbu
country: China
facility: The 123 Hospital of PLA
city: Changzhou
country: China
facility: Changzhou Fouth People's Hospital
city: Huai'an
country: China
facility: Huaian Second People's Hospital
city: Huainan
country: China
facility: Huainan Eastern Hospital
city: Huainan
country: China
facility: Huainan Xinhua Hospital
city: Ma'anshan
country: China
facility: Maanshan Shiqiye Hospital
city: Muyang
country: China
facility: Muyang Traditional Chinese Medicine Hospital
city: Nanjing
country: China
facility: Nanjing First Hospital
city: Nanjing
country: China
facility: Nanjing Pukou Central Hospital
city: Nanjing
country: China
facility: Nnajing 81 Hospital
city: Nanjing
country: China
facility: Nnajing Integrated Traditional Chinese and Westem Medicine Hospital
city: Taicang
country: China
facility: Taicang First People's Hospital
city: Wuxi
country: China
facility: Wuxi Third Hospital
city: Wuxi
country: China
facility: Yixin People's Hospital
city: Wuxi
country: China
facility: Yixing Traditional Chinese Medicine Hospital
city: Xuancheng
country: China
facility: Xuncheng Central Hospital
city: Zhangjiagang
country: China
facility: Zhangjiagang First People's Hospital
Study officials:
affiliation: Nanjing First Hospital, Nanjing Medical University
name: Shaoliang Chen, PhD
role: STUDY_CHAIR
References:
citation: 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.