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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03051048
Other study ID # NFH20170208
Secondary ID
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
Health authority
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

Study Design


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
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