Coronary Heart Disease Clinical Trial
— MOODYOfficial title:
System Delay and Clinical Outcome Among Chinese Patients With AMI Treated With Reperfusion Therapy (MOODY Study)
Verified date | December 2017 |
Source | Nanjing First Hospital, Nanjing Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 8000 |
Est. completion date | September 30, 2017 |
Est. primary completion date | June 30, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
China | Anqing First People's Hospital | Anqing | |
China | The 123 Hospital of PLA | Bengbu | |
China | Changshu First People's Hospital | Changshu | Jiangsu |
China | Changzhou Fouth People's Hospital | Changzhou | |
China | Changzhou Traditional Chinese Medicine Hospital | Changzhou | Jiangsu |
China | Huaian Second People's Hospital | Huai'an | |
China | Huainan Eastern Hospital | Huainan | |
China | Huainan Xinhua Hospital | Huainan | |
China | Jintan People's Hospital | Jintan | Jiangsu |
China | Liyang Hospital of TCM | Liyang | Jiangsu |
China | Maanshan Shiqiye Hospital | Ma'anshan | |
China | Muyang Traditional Chinese Medicine Hospital | Muyang | |
China | Gaochun People's Hospital | Nanjing | Jiangsu |
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 | Nanjing | |
China | Taicang First People's Hospital | Taicang | |
China | Wuxi Third Hospital | Wuxi | |
China | Yixin People's Hospital | Wuxi | |
China | Yixing Traditional Chinese Medicine Hospital | Wuxi | |
China | Xuncheng Central Hospital | Xuancheng | |
China | Zhangjiagang First People's Hospital | Zhangjiagang |
Lead Sponsor | Collaborator |
---|---|
Nanjing First Hospital, Nanjing Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 30-Day Freedom From Mortality | All-cause death | 30 days | |
Secondary | 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 | |
Secondary | Cardiac death | Death that could not be attributed to a noncardiac etiology was considered cardiac death. | 12 months | |
Secondary | 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 | |
Secondary | Target vessel revascularization | Target vessel revascularization was defined as repeated revascularization by PCI or surgery of the target vessel. | 12 months |
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