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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03051048
Recruitment Status : Completed
First Posted : February 13, 2017
Last Update Posted : December 6, 2017
Sponsor:
Information provided by (Responsible Party):
Shaoliang Chen, Nanjing First Hospital, Nanjing Medical University

Brief 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.

Condition or disease Intervention/treatment
Coronary Heart Disease Procedure: Reperfusion

Detailed 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.

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Study Type : Observational
Actual Enrollment : 8000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: System Delay and Clinical Outcome Among Chinese Patients With AMI Treated With Reperfusion Therapy (MOODY Study)
Actual Study Start Date : January 1, 1999
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : September 30, 2017

Group/Cohort Intervention/treatment
Group 1
The patient received reperfusion therapy between 1999 January 1 and 2009 December 31
Procedure: Reperfusion
Group 2
The patient received reperfusion therapy between 2010 January 1 and 2016 December 31
Procedure: Reperfusion



Primary Outcome Measures :
  1. 30-Day Freedom From Mortality [ Time Frame: 30 days ]
    All-cause death


Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
In China, hospitalized patients with acute myocardial infarction will be enrolled consecutively.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03051048


Locations
Show Show 23 study locations
Sponsors and Collaborators
Nanjing First Hospital, Nanjing Medical University
Investigators
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Study Chair: Shaoliang Chen, PhD Nanjing First Hospital, Nanjing Medical University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Shaoliang Chen, Vice President, Nanjing First Hospital, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT03051048    
Other Study ID Numbers: NFH20170208
First Posted: February 13, 2017    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shaoliang Chen, Nanjing First Hospital, Nanjing Medical University:
Acute Myocardial Infarction
Additional relevant MeSH terms:
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Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases