Acute Myocardial InfarctionNCT03238508
Index of Microcirculatory Resistance After Immediate Versus Deferred Stenting in Patients With Acute Myocardial Infarction
An observational study of Acute Myocardial Infarction, run by Sejong General Hospital at 1 site in South Korea.
Trial summary
This study will compare the microcirculatory resistance (IMR) of infarct-related artery (IRA) in patients who underwent immediate versus deferred stenting during percutaneous coronary intervention (PCI) for acute myocardial infarction. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Deferred stenting
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2013to 30 Sep 2017
- How long will I take part?
- 1 Year
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing primary precutaneous coronary intervention for ST- segment elevation or Non ST-segment elevation myocardial infarcation with ongoing myocardial ischemia
Who may be able to join
- More than 30 minutes in duration of typical chest pain
- Thrombolysis In Myocardial Infarction (TIMI) flow 0, 1 or 2 prior to the procedure
Who cannot join
- Cardiogenic shock,
- Previous history of myocardial infarction, or coronary artery bypass surgery
- Rescue PCI after fibrinolysis
- Life expectancy of less than 1 year
- Acute occlusion of left main coronary artery
- STEMI due to stent thrombosis
- Major coronary dissection (type D~F) following procedures achieving TIMI 3 flow
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Sejong general hospital, 91-121 Sosa 2-Dong, Sosa-Gu
Bucheon-si, Gyeonggi-do, 422-711
Hyun-Jong Lee, MD, 82-32-340-1812, untouchables@sejongh.co.kr
About this study
This study will compare the microcirculatory resistance (IMR) of infarct-related artery (IRA) in patients who underwent immediate versus deferred stenting during percutaneous coronary intervention (PCI) for acute myocardial infarction.
Read the detailed description
Primary PCI with immediate stenting (IS) is the current standard of reperfusion strategy for STEMI. However, it is thought that IS may cause additional myocardial injury by increasing distal embolization of clot and atheromatous plaque debris. Only about 35% of patients without cardiogenic shock can achieve optimal myocardial tissue perfusion at the microvascular level, even after restoration of epicardial coronary artery patency. IS in highly pro-thrombotic and inflammatory milieu of IRA during primary PCI would increase distal embolization of clot and atheromatous plaque debris, and provoke the inflammation process, so deferred stenting after a cooling down period of IRA for several days, have a potential to mitigate or prevent microvascular obstruction (MVO). Among several methods to evaluate MVO after STEMI, IMR has been well known as an good indicator of MVO and strong predictor for short and long term clinical outcomes.
- Conditions
- Acute Myocardial Infarction
- Being tested
- Deferred stenting
- Keywords
- Deferred stenting, Microvascular dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deferred stentingProcedure or surgery
Previously described
| Study group | Role | What they receive |
|---|---|---|
| Immediate stenting group | Conventional stenting immediate after the re-opening of infarct-related artery during primary PCI | |
| Deferred stenting group | Elective stenting following cooling down of infarct- related artery for several days after restoration of epicardial coronary blood flow during primary PCI Receives: Procedure: Deferred stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Index of microcirculatory resistance of infarct-related artery
Measured by pressure and temperature sensors- tipped guide wire
Measured: 3 to 5 days after primary reperfusion (TIMI 3 flow achievement) in both groups
Secondary outcomes (3)
The rate of urgent revascularization
Measured: During index hospitalization (intraoperative)
Major bleeding
Defined as TIMI bleeding criteria
Measured: During index hospitalization (intraoperative)
Major adverse cardiac events
Death, myocardial infarction, unplanned target vessel revascularization or CHF admission
Measured: One- year after primary reperfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2017
- Study start1 Jan 2013
- Primary completion30 Aug 2017 (estimated)
- Study completion30 Sep 2017 (estimated)
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 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
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Sejong General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyun Jong Lee, Sejong General Hospital
- Investigators
- Hyun Jong Lee, MD, Principal investigator, Sejong General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03238508
- Sponsor's protocol ID
- Sejong_IRB_1732
- Status last verified
- Aug 2017
- First submitted
- 1 Aug 2017
- Last updated
- 8 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim JS, Lee HJ, Woong Yu C, Kim YM, Hong SJ, Park JH, Choi RK, Choi YJ, Park JS, Kim TH, Jang HJ, Joo HJ, Cho SA, Ro YM, Lim DS. INNOVATION Study (Impact of Immediate Stent Implantation Versus Deferred Stent Implantation on Infarct Size and Microvascular Perfusion in Patients With ST-Segment-Elevation Myocardial Infarction). Circ Cardiovasc Interv. 2016 Dec;9(12):e004101. doi: 10.1161/CIRCINTERVENTIONS.116.004101.
PubMed 27965296
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Index of Microcirculatory Resistance After Immediate Versus Deferred Stenting in Patients With Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT03238508
- Acronym / sponsor ID
- Sejong_IRB_1732
- Conditions
- Acute Myocardial Infarction
- Keywords
- Deferred stenting, Microvascular dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sejong General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 30 Aug 2017 (estimated)
- Study completion
- 30 Sep 2017 (estimated)
- First posted
- 3 Aug 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.
This study will compare the microcirculatory resistance (IMR) of infarct-related artery (IRA) in patients who underwent immediate versus deferred stenting during percutaneous coronary intervention (PCI) for acute myocardial infarction.
Detailed description
Primary PCI with immediate stenting (IS) is the current standard of reperfusion strategy for STEMI. However, it is thought that IS may cause additional myocardial injury by increasing distal embolization of clot and atheromatous plaque debris. Only about 35% of patients without cardiogenic shock can achieve optimal myocardial tissue perfusion at the microvascular level, even after restoration of epicardial coronary artery patency. IS in highly pro-thrombotic and inflammatory milieu of IRA during primary PCI would increase distal embolization of clot and atheromatous plaque debris, and provoke the inflammation process, so deferred stenting after a cooling down period of IRA for several days, have a potential to mitigate or prevent microvascular obstruction (MVO). Among several methods to evaluate MVO after STEMI, IMR has been well known as an good indicator of MVO and strong predictor for short and long term clinical outcomes.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate stenting group | – | –Conventional stenting immediate after the re-opening of infarct-related artery during primary PCI |
| Deferred stenting group | – | Procedure: Deferred stentingElective stenting following cooling down of infarct- related artery for several days after restoration of epicardial coronary blood flow during primary PCI |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing primary precutaneous coronary intervention for ST- segment elevation or Non ST-segment elevation myocardial infarcation with ongoing myocardial ischemia
Key inclusion criteria (2 listed)
- More than 30 minutes in duration of typical chest pain
- Thrombolysis In Myocardial Infarction (TIMI) flow 0, 1 or 2 prior to the procedure
Key exclusion criteria (7 listed)
- Cardiogenic shock,
- Previous history of myocardial infarction, or coronary artery bypass surgery
- Rescue PCI after fibrinolysis
- Life expectancy of less than 1 year
- Acute occlusion of left main coronary artery
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 |
|---|---|---|
| Deferred stentingPreviously described | Procedure or surgery | Deferred stenting group |
Primary outcome
Index of microcirculatory resistance of infarct-related artery
Time frame: 3 to 5 days after primary reperfusion (TIMI 3 flow achievement) in both groups
Measured by pressure and temperature sensors- tipped guide wire
3 secondary outcomes
The rate of urgent revascularization
Time frame: During index hospitalization (intraoperative)
Major bleeding
Time frame: During index hospitalization (intraoperative)
Major adverse cardiac events
Time frame: One- year after primary reperfusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2017.
- Background: PubMed 27965296Kim JS, Lee HJ, Woong Yu C, Kim YM, Hong SJ, Park JH, Choi RK, Choi YJ, Park JS, Kim TH, Jang HJ, Joo HJ, Cho SA, Ro YM, Lim DS. INNOVATION Study (Impact of Immediate Stent Implantation Versus Deferred Stent Implantation on Infarct Size and Microvascular Perfusion in Patients With ST-Segment-Elevation Myocardial Infarction). Circ Cardiovasc Interv. 2016 Dec;9(12):e004101. doi: 10.1161/CIRCINTERVENTIONS.116.004101.
- 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.
Hyun Jong Lee, MD principal investigator
Sejong General Hospital
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 Sejong General Hospital at 1 site in South Korea.
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 2 inclusion and 7 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 8 Aug 2017. 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 South Korea. 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 Hyun Jong Lee, MD (82-32-340-1812, untouchables@sejongh.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Index of microcirculatory resistance of infarct-related artery (time frame: 3 to 5 days after primary reperfusion (TIMI 3 flow achievement) in both groups). 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 NCT03238508, 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 8 Aug 2017.