System Delay and Clinical Outcome Among Chinese Patients With AMI Treated With Reperfusion Therapy (MOODY Study) (MOODY)
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| ClinicalTrials.gov Identifier: NCT03051048 |
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Recruitment Status :
Completed
First Posted : February 13, 2017
Last Update Posted : December 6, 2017
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| Condition or disease | Intervention/treatment |
|---|---|
| Coronary Heart Disease | Procedure: Reperfusion |
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.
| 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 |
|---|---|
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Group 1
The patient received reperfusion therapy between 1999 January 1 and 2009 December 31
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Procedure: Reperfusion |
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Group 2
The patient received reperfusion therapy between 2010 January 1 and 2016 December 31
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Procedure: Reperfusion |
- 30-Day Freedom From Mortality [ Time Frame: 30 days ]All-cause death
- 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.
- Cardiac death [ Time Frame: 12 months ]Death that could not be attributed to a noncardiac etiology was considered cardiac death.
- 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.
- 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 |
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
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
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| Study Chair: | Shaoliang Chen, PhD | Nanjing First Hospital, Nanjing Medical University |
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Acute Myocardial Infarction |
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Heart Diseases Coronary Disease Coronary Artery Disease Myocardial Ischemia |
Cardiovascular Diseases Vascular Diseases Arteriosclerosis Arterial Occlusive Diseases |