Acute Myocardial InfarctionNCT02576691
Effects of Percutaneous Coronary Intervention in Patients With Cardiac Arrest After Acute Myocardial Infarction: a 2-Year Study
An observational study of Acute Myocardial Infarction, run by Yuanli Lei.
Trial summary
The purpose of this study is To assess percutaneous coronary intervention 's effect on short- and long- term outcomes, and complication incidence in resuscitated victims of cardiac arrest after acute myocardial infarction Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- percutaneous coronary intervention
- Type of treatment
- Medical device
- How many people
- 2,363 participants
- Where
- No sites listed yet
- Study dates
- Jan 2005to Apr 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 20 million residents of the South of Zhejiang Province
Who may be able to join
- underwent successful cardiopulmonary resuscitation from CA after AMI
Who cannot join
- late tumor;
- underwent Coronary Artery Bypass Grafting after CAG;
- with no attempted resuscitation.
About this study
The purpose of this study is To assess percutaneous coronary intervention 's effect on short- and long- term outcomes, and complication incidence in resuscitated victims of cardiac arrest after acute myocardial infarction
- Conditions
- Acute Myocardial Infarction
- Being tested
- percutaneous coronary intervention
- Keywords
- cardiac arrest, percutaneous coronary intervention, cardiogenic shock, outcome
- Medical subject headings
- Heart Arrest, Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous coronary interventionDevice
| Study group | Role | What they receive |
|---|---|---|
| The PCI group | The PCI group was composed of patients who underwent PCI following the return of spontaneous circulation or after CA. Receives: Device: percutaneous coronary intervention | |
| Non-PCI group | Non-PCI group included patients who didn't undergo PCI or were subjected to PCI before CA |
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause mortality
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2015 (estimated)
- Study startJan 2005
- Primary completionApr 2013
- Study completionApr 2015
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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 2,363 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuanli Lei
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yuanli Lei, Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02576691
- Sponsor's protocol ID
- Yuanli2015
- Status last verified
- Oct 2015
- First submitted
- 13 Oct 2015
- Last updated
- 15 Oct 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Percutaneous Coronary Intervention in Patients With Cardiac Arrest After Acute Myocardial Infarction: a 2-Year Study
- ClinicalTrials.gov ID
- NCT02576691
- Acronym / sponsor ID
- Yuanli2015
- Conditions
- Acute Myocardial Infarction
- Keywords
- cardiac arrest, percutaneous coronary intervention, cardiogenic shock, outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,363 participants (actual)
- Lead sponsor
- Yuanli LeiUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 15 Oct 2015 (estimated)
- 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 purpose of this study is To assess percutaneous coronary intervention 's effect on short- and long- term outcomes, and complication incidence in resuscitated victims of cardiac arrest after acute myocardial infarction
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The PCI group | – | Device: percutaneous coronary interventionThe PCI group was composed of patients who underwent PCI following the return of spontaneous circulation or after CA. |
| Non-PCI group | – | –Non-PCI group included patients who didn't undergo PCI or were subjected to PCI before CA |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 20 million residents of the South of Zhejiang Province
Key inclusion criteria (1 listed)
- underwent successful cardiopulmonary resuscitation from CA after AMI
Key exclusion criteria (3 listed)
- late tumor;
- underwent Coronary Artery Bypass Grafting after CAG;
- with no attempted resuscitation.
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 |
|---|---|---|
| percutaneous coronary intervention | Device | The PCI group |
Primary outcome
all cause mortality
Time frame: 2 years
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 15 Oct 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myocardial Infarction, run by Yuanli Lei.
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 3 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 15 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
all cause mortality (time frame: 2 years). 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 15 Oct 2015.