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

NCT ID: NCT03051048

Last Updated: 2017-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

8000 participants

Study Classification

OBSERVATIONAL

Study Start Date

1999-01-01

Study Completion Date

2017-09-30

Brief Summary

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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

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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.

Conditions

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Coronary Heart Disease

Keywords

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Acute Myocardial Infarction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

The patient received reperfusion therapy between 1999 January 1 and 2009 December 31

Reperfusion

Intervention Type PROCEDURE

Group 2

The patient received reperfusion therapy between 2010 January 1 and 2016 December 31

Reperfusion

Intervention Type PROCEDURE

Interventions

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Reperfusion

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Shaoliang Chen

Vice President

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shaoliang Chen, PhD

Role: STUDY_CHAIR

Nanjing First Hospital, Nanjing Medical University

Locations

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Changshu First People's Hospital

Changshu, Jiangsu, China

Site Status

Changzhou Traditional Chinese Medicine Hospital

Changzhou, Jiangsu, China

Site Status

Jintan People's Hospital

Jintan, Jiangsu, China

Site Status

Liyang Hospital of TCM

Liyang, Jiangsu, China

Site Status

Gaochun People's Hospital

Nanjing, Jiangsu, China

Site Status

Anqing First People's Hospital

Anqing, , China

Site Status

The 123 Hospital of PLA

Bengbu, , China

Site Status

Changzhou Fouth People's Hospital

Changzhou, , China

Site Status

Huaian Second People's Hospital

Huai'an, , China

Site Status

Huainan Eastern Hospital

Huainan, , China

Site Status

Huainan Xinhua Hospital

Huainan, , China

Site Status

Maanshan Shiqiye Hospital

Ma’anshan, , China

Site Status

Muyang Traditional Chinese Medicine Hospital

Muyang, , China

Site Status

Nanjing First Hospital

Nanjing, , China

Site Status

Nanjing Pukou Central Hospital

Nanjing, , China

Site Status

Nnajing 81 Hospital

Nanjing, , China

Site Status

Nnajing Integrated Traditional Chinese and Westem Medicine Hospital

Nanjing, , China

Site Status

Taicang First People's Hospital

Taicang, , China

Site Status

Wuxi Third Hospital

Wuxi, , China

Site Status

Yixin People's Hospital

Wuxi, , China

Site Status

Yixing Traditional Chinese Medicine Hospital

Wuxi, , China

Site Status

Xuncheng Central Hospital

Xuancheng, , China

Site Status

Zhangjiagang First People's Hospital

Zhangjiagang, , China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 30755362 (View on PubMed)

Other Identifiers

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NFH20170208

Identifier Type: -

Identifier Source: org_study_id