Acute Myocardial InfarctionNCT04952740
Application of Index of Microcirculatory Resistance to Evaluate Myocardial Protection After Ischemic Adaptation
A study testing IPC+PCI and No IPC in people with Acute Myocardial Infarction, run by Peking University Third Hospital at 1 site in China.
Trial summary
To evaluate the protective effect of IPC on the myocardial microcirculation response through IMR and the predictive value of IMR on the degree of myocardial reperfusion and the prognosis of patients. 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?
- IPC+PCI and No IPC
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2014to 30 Jun 2015
- Phase
- Interventional
- 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
Who may be able to join
- Age ≥ 18 years old, no gender limit;
- First episode of STEMI (diagnostic criteria: ischemic chest pain lasting ≥30min; ST-segment elevation in two or more adjacent leads on the ECG or new left bundle branch block; with or without elevated myocardial markers), The onset time is within 12 hours, and emergency interventional treatment is planned;
- Agree and cooperate to participate in this research.
Who cannot join
- Old myocardial infarction;
- Killip grade of cardiac function ≥ grade III or cardiogenic shock;
- Systolic blood pressure ≤100mmHg;
- Bradycardia, HR<60pbm, or AVB above II degree;
- Past history of asthma or severe COPD;
- Severe liver and kidney dysfunction.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University third hospital
Beijing, Beijing Municipality, 100089
About this study
To evaluate the protective effect of IPC on the myocardial microcirculation response through IMR and the predictive value of IMR on the degree of myocardial reperfusion and the prognosis of patients.
Read the detailed description
This study is a clinical randomized controlled study, applying index of microcirculatory resistance (IMR) to evaluate the myocardial protection of ischemic postconditioning (IPC) in patients receiving direct PCI treatment for acute myocardial infarction.IMR is a quantitative evaluation index of microcirculation status. IPC has been reported to reduce ischemia-reperfusion injury and has a myocardial protective effect.The research plan divides patients into IPC and non-IPC groups at random. After the infarction-related artery is successfully implanted with a stent, the pressure guide wire is used to measure IMR and CFR in the state of maximal expansion of the microcirculation induced by intravenous ATP infusion.And analyze whether there are differences in indicators between the two groups and the relationship between these indicators and the patient's myocardial level reperfusion, cardiac function and prognosis.The purpose is to evaluate the myocardial protection of IPC and the predictive value of IMR on the degree of myocardial reperfusion and the prognosis of patients. It is expected that the target IPC can improve the IMR value, and IMR can predict the degree of myocardial reperfusion and cardiac function and prognosis.
- Conditions
- Acute Myocardial Infarction
- Being tested
- IPC+PCI, No IPC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPC+PCIProcedure or surgery
Also called Ischemic postconditioning
Routine PCI operations (including thrombus aspiration, stent injection, application of GPIIb/IIIa, etc.) + immediate post-ischemic adaptation: 30 seconds balloon inflation and 30 seconds deflation for 3 cycles
No IPCProcedure or surgery
Also called Routine PCI
Routine PCI operations (including thrombus aspiration, stent injection, application of GPIIb/IIIa, etc.
| Study group | Role | What they receive |
|---|---|---|
| Ischemic postconditioning | Experimental | Routine PCI operations (including thrombus aspiration, stent injection, application of GPIIb/IIIa, etc.) + immediate post-ischemic adaptation: 30 seconds balloon inflation and 30 seconds deflation for 3 cycles Receives: Procedure: IPC+PCI |
| No Ischemic postconditioning | Active comparator | Routine PCI operations (including thrombus aspiration, stent injection, application of GPIIb/IIIa, etc.) Receives: Procedure: No IPC |
What is being measured
The primary outcome is the main question the study is designed to answer.
IMR
index of microcirculatory resistance measured during coronary intervention.
Measured: detected immediately after percutaneous coronary intervention
Secondary outcomes (1)
MACEs after PCI
MACEs includes cardiogenic death, non-fatal myocardial infarction, malignant arrhythmia, unplanned revascularization, unstable angina pectoris requiring hospitalization and severe heart failure requiring hospitalization
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start1 Jan 2014
- Primary completion31 Dec 2014
- Study completion30 Jun 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.
- More trials run by Peking University Third HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lijun Lijun, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04952740
- Sponsor's protocol ID
- 2013127
- Status last verified
- Jan 2014
- First submitted
- 29 Jun 2021
- Last updated
- 9 Jul 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 9 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Index of Microcirculatory Resistance to Evaluate Myocardial Protection After Ischemic Adaptation
- ClinicalTrials.gov ID
- NCT04952740
- Acronym / sponsor ID
- 2013127
- Conditions
- Acute Myocardial Infarction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2014 (actual)
- Study completion
- 30 Jun 2015 (actual)
- First posted
- 7 Jul 2021 (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.
To evaluate the protective effect of IPC on the myocardial microcirculation response through IMR and the predictive value of IMR on the degree of myocardial reperfusion and the prognosis of patients.
Detailed description
This study is a clinical randomized controlled study, applying index of microcirculatory resistance (IMR) to evaluate the myocardial protection of ischemic postconditioning (IPC) in patients receiving direct PCI treatment for acute myocardial infarction.IMR is a quantitative evaluation index of microcirculation status. IPC has been reported to reduce ischemia-reperfusion injury and has a myocardial protective effect.The research plan divides patients into IPC and non-IPC groups at random. After the infarction-related artery is successfully implanted with a stent, the pressure guide wire is used to measure IMR and CFR in the state of maximal expansion of the microcirculation induced by intravenous ATP infusion.And analyze whether there are differences in indicators between the two groups and the relationship between these indicators and the patient's myocardial level reperfusion, cardiac function and prognosis.The purpose is to evaluate the myocardial protection of IPC and the predictive value of IMR on the degree of myocardial reperfusion and the prognosis of patients. It is expected that the target IPC can improve the IMR value, and IMR can predict the degree of myocardial reperfusion and cardiac function and prognosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ischemic postconditioning | Experimental | Procedure: IPC+PCIRoutine PCI operations (including thrombus aspiration, stent injection, application of GPIIb/IIIa, etc.) + immediate post-ischemic adaptation: 30 seconds balloon inflation and 30 seconds deflation for 3 cycles |
| No Ischemic postconditioning | Active comparator | Procedure: No IPCRoutine PCI operations (including thrombus aspiration, stent injection, application of GPIIb/IIIa, etc.) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years old, no gender limit;
- First episode of STEMI (diagnostic criteria: ischemic chest pain lasting ≥30min; ST-segment elevation in two or more adjacent leads on the ECG or new left bundle branch block; with or without elevated myocardial markers), The onset time is within 12 hours, and emergency interventional treatment is planned;
- Agree and cooperate to participate in this research.
Key exclusion criteria (6 listed)
- Old myocardial infarction;
- Killip grade of cardiac function ≥ grade III or cardiogenic shock;
- Systolic blood pressure ≤100mmHg;
- Bradycardia, HR<60pbm, or AVB above II degree;
- Past history of asthma or severe COPD;
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 |
|---|---|---|
| IPC+PCIAlso: Ischemic postconditioningRoutine PCI operations (including thrombus aspiration, stent injection, application of GPIIb/IIIa, etc.) + immediate post-ischemic adaptation: 30 seconds balloon inflation and 30 seconds deflation for 3 cycles | Procedure or surgery | Ischemic postconditioning |
| No IPCAlso: Routine PCIRoutine PCI operations (including thrombus aspiration, stent injection, application of GPIIb/IIIa, etc. | Procedure or surgery | No Ischemic postconditioning |
Primary outcome
IMR
Time frame: detected immediately after percutaneous coronary intervention
index of microcirculatory resistance measured during coronary intervention.
1 secondary outcome
MACEs after PCI
Time frame: 6 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 9 Jul 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.
Lijun Lijun principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IPC+PCI and No IPC in people with Acute Myocardial Infarction, run by Peking University Third Hospital 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 3 inclusion and 6 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 9 Jul 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?
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?
IMR (time frame: detected immediately after percutaneous coronary intervention). 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 9 Jul 2021.