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Completed

NCT Number: NCT03051048

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Changshu First People's Hospital, Changshu, Jiangsu, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Reperfusion

Procedure

Primary outcomes

  1. 30-Day Freedom From Mortality

    Time frame: 30 days

    All-cause death

Secondary outcomes

  1. 12-Month Freedom From Major Adverse Cardiac Events (MACE)

    Time frame: 12 months

    Composite of MACE including cardiac death, non-fatal AMI, and clinically driven target vessel revascularization.

  2. Cardiac death

    Time frame: 12 months

    Death that could not be attributed to a noncardiac etiology was considered cardiac death.

  3. Myocardial infarction

    Time frame: 12 months

    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.

  4. Target vessel revascularization

    Time frame: 12 months

    Target vessel revascularization was defined as repeated revascularization by PCI or surgery of the target vessel.

Sponsors and collaborators

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Other

Registry information

Acronym: MOODY

Important dates

Study start
1999
Primary completion
2017
Study completion
2017
First posted
Feb 13, 2017
Registry last updated
Dec 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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