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

Coronary Heart Disease Clinical Trial

— MOODY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03051048
• Other study ID #: NFH20170208
• Status: Completed
• Phase: N/A
• First received: February 9, 2017
• Last updated: December 5, 2017
• Start date: January 1, 1999
• Est. completion date: September 30, 2017

Study information

• Verified date: December 2017
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Procedure:
• Reperfusion

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

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