Acute Myocardial InfarctionNCT04172168
Left Ventricular Free-wall Ruptrue After Acute Myocardial Infarction (LVFR-AMI)
An observational study of Acute Myocardial Infarction, run by Xiamen Cardiovascular Hospital, Xiamen University at 1 site in China.
Trial summary
The Left Ventricular Free-wall Ruptrue (LVFR) is a serious complication caused high mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Heart rupture
- How many people
- 17,568 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2011to 31 Mar 2021
- 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: The study population of acute myocardial infarction (STEMI or NSTEMI) patients.
Who may be able to join
- Patients be admitted for acute myocardial infarction (STEMI or NSTEMI)
Who cannot join
- Non-cardiovascular comorbidity for AMI
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xiamen Cardiovascular Hospital Xiamen University
Xiamen, Fujian, 361000
Bin Wang, Ph.D, +8613400664305, mocw361@163.com
About this study
Official title: Clinical Characteristics of Left Ventricular Free-wall Ruptrue After Acute Myocardial Infarction
The Left Ventricular Free-wall Ruptrue (LVFR) is a serious complication caused high mortality.
Read the detailed description
The actual mortality of LVFR is close to 100%. Despite the mortality rate for LVFR has been decreasing with the development of reperfusion therapy, the serious complication remains a difficult challenge. The coronary anatomy distribution associated with LVFR has an interesting phenomenon. From the perspective of different coronary distribution, we can better known the risk factors related to LVFR.
- Conditions
- Acute Myocardial Infarction
- Being tested
- Heart rupture
- Keywords
- Left Ventricular Free-wall Ruptrue, Acute myocardial infarction, Coronary angiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart ruptureDiagnostic test
Left ventricular free-wall ruptrue after AMI
| Study group | Role | What they receive |
|---|---|---|
| Heart rupture | Include left ventricular free-wall ruptrue after AMI Receives: Diagnostic Test: Heart rupture | |
| Non heart rupture | AMI with non heart rupture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of heart ruputre
Left Ventricular Free-wall Ruptrue
Measured: Mortality 30 days
Secondary outcomes (2)
Rate of cardiogenic shock
Cardiogenic shock After AMI
Measured: Hospitalization 30 days
Rate of cardiac arrest
Cardiac arrest After AMI
Measured: Hospitalization 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start1 Jan 2011
- Primary completion31 Dec 2019
- Study completion31 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- 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
- 17,568 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiamen Cardiovascular Hospital, Xiamen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yan Wang, Xiamen Cardiovascular Hospital, Xiamen University
- Investigators
- Yan Wang, PhD, Study chair, Cardiovascular Hospital, Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04172168
- Sponsor's protocol ID
- 9215443689
- Status last verified
- Mar 2021
- First submitted
- 18 Nov 2019
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics of Left Ventricular Free-wall Ruptrue After Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT04172168
- Acronym / sponsor ID
- 9215443689
- Conditions
- Acute Myocardial Infarction
- Keywords
- Left Ventricular Free-wall Ruptrue, Acute myocardial infarction, Coronary angiography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 17,568 participants (estimated)
- Lead sponsor
- Xiamen Cardiovascular Hospital, Xiamen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 21 Nov 2019 (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.
The Left Ventricular Free-wall Ruptrue (LVFR) is a serious complication caused high mortality.
Detailed description
The actual mortality of LVFR is close to 100%. Despite the mortality rate for LVFR has been decreasing with the development of reperfusion therapy, the serious complication remains a difficult challenge. The coronary anatomy distribution associated with LVFR has an interesting phenomenon. From the perspective of different coronary distribution, we can better known the risk factors related to LVFR.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heart rupture | – | Diagnostic Test: Heart ruptureInclude left ventricular free-wall ruptrue after AMI |
| Non heart rupture | – | –AMI with non heart rupture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population of acute myocardial infarction (STEMI or NSTEMI) patients.
Key inclusion criteria (1 listed)
- Patients be admitted for acute myocardial infarction (STEMI or NSTEMI)
Key exclusion criteria (1 listed)
- Non-cardiovascular comorbidity for AMI
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 |
|---|---|---|
| Heart ruptureLeft ventricular free-wall ruptrue after AMI | Diagnostic test | Heart rupture |
Primary outcome
Rate of heart ruputre
Time frame: Mortality 30 days
Left Ventricular Free-wall Ruptrue
2 secondary outcomes
Rate of cardiogenic shock
Time frame: Hospitalization 30 days
Rate of cardiac arrest
Time frame: Hospitalization 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- 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.
Yan Wang, PhD study chair
Cardiovascular Hospital, Xiamen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myocardial Infarction, run by Xiamen Cardiovascular Hospital, Xiamen University at 1 site 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: status not confirmed, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yan Wang, PhD (+8613860488088, wy@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of heart ruputre (time frame: Mortality 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Apr 2021.