Coronary Heart DiseaseMOODYNCT03051048
System Delay and Clinical Outcome Among Chinese Patients With AMI Treated With Reperfusion Therapy (MOODY Study)
An observational study of Coronary Heart Disease, run by Nanjing First Hospital, Nanjing Medical University at 23 sites in China.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- Reperfusion
- Type of treatment
- Surgery or procedure
- How many people
- 8,000 participants
- Where
- 23 sitesChina
- Study dates
- 1 Jan 1999to 30 Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In China, hospitalized patients with acute myocardial infarction will be enrolled consecutively.
Who may be able to join
- 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).
Who cannot join
- Previously enrolled in the similar study
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
China23 sites
Anqing First People's Hospital
Anqing
The 123 Hospital of PLA
Bengbu
Changshu First People's Hospital
Changshu, Jiangsu
Changzhou Traditional Chinese Medicine Hospital
Changzhou, Jiangsu
Changzhou Fouth People's Hospital
Changzhou
Huaian Second People's Hospital
Huai'an
Huainan Eastern Hospital
Huainan
Huainan Xinhua Hospital
Huainan
Jintan People's Hospital
Jintan, Jiangsu
Liyang Hospital of TCM
Liyang, Jiangsu
Maanshan Shiqiye Hospital
Ma’anshan
Muyang Traditional Chinese Medicine Hospital
Muyang
Gaochun People's Hospital
Nanjing, Jiangsu
Nanjing First Hospital
Nanjing
Nanjing Pukou Central Hospital
Nanjing
Nnajing 81 Hospital
Nanjing
Nnajing Integrated Traditional Chinese and Westem Medicine Hospital
Nanjing
Taicang First People's Hospital
Taicang
Wuxi Third Hospital
Wuxi
Yixin People's Hospital
Wuxi
Yixing Traditional Chinese Medicine Hospital
Wuxi
Xuncheng Central Hospital
Xuancheng
Zhangjiagang First People's Hospital
Zhangjiagang
About this 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.
Read the 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.
- Conditions
- Coronary Heart Disease
- Being tested
- Reperfusion
- Keywords
- Acute Myocardial Infarction
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReperfusionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | The patient received reperfusion therapy between 1999 January 1 and 2009 December 31 Receives: Procedure: Reperfusion | |
| Group 2 | The patient received reperfusion therapy between 2010 January 1 and 2016 December 31 Receives: Procedure: Reperfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-Day Freedom From Mortality
All-cause death
Measured: 30 days
Secondary outcomes (4)
12-Month Freedom From Major Adverse Cardiac Events (MACE)
Composite of MACE including cardiac death, non-fatal AMI, and clinically driven target vessel revascularization.
Measured: 12 months
Cardiac death
Death that could not be attributed to a noncardiac etiology was considered cardiac death.
Measured: 12 months
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.
Measured: 12 months
Target vessel revascularization
Target vessel revascularization was defined as repeated revascularization by PCI or surgery of the target vessel.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2017
- Study start1 Jan 1999
- Primary completion30 Jun 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8,000 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaoliang Chen, Nanjing First Hospital, Nanjing Medical University
- Investigators
- Shaoliang Chen, PhD, Study chair, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03051048
- Sponsor's protocol ID
- NFH20170208
- Acronym
- MOODY
- Status last verified
- Dec 2017
- First submitted
- 9 Feb 2017
- Last updated
- 6 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30755362
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- System Delay and Clinical Outcome Among Chinese Patients With AMI Treated With Reperfusion Therapy (MOODY Study)
- ClinicalTrials.gov ID
- NCT03051048
- Acronym / sponsor ID
- MOODY / NFH20170208
- Conditions
- Coronary Heart Disease
- Keywords
- Acute Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,000 participants (actual)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 1999 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 13 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Procedure: ReperfusionThe patient received reperfusion therapy between 1999 January 1 and 2009 December 31 |
| Group 2 | – | Procedure: ReperfusionThe patient received reperfusion therapy between 2010 January 1 and 2016 December 31 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In China, hospitalized patients with acute myocardial infarction will be enrolled consecutively.
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- Previously enrolled in the similar study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reperfusion | Procedure or surgery | Group 1, Group 2 |
Primary outcome
30-Day Freedom From Mortality
Time frame: 30 days
All-cause death
4 secondary outcomes
12-Month Freedom From Major Adverse Cardiac Events (MACE)
Time frame: 12 months
Cardiac death
Time frame: 12 months
Myocardial infarction
Time frame: 12 months
Target vessel revascularization
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2017.
- Derived from this study: PubMed 30755362Xue 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shaoliang Chen, PhD study chair
Nanjing First Hospital, Nanjing Medical University
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Heart Disease, run by Nanjing First Hospital, Nanjing Medical University at 23 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-Day Freedom From Mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03051048, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2017.