Myocardial ReperfusionPOSTNCT00942500
Effects of Postconditioning On Myocardial Reperfusion
A study testing Post-conditioning in people with Myocardial Reperfusion and Myocardial Infarction, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate the effects of postconditioning on myocardial reperfusion in patients with ST-segment elevation myocardial infarction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Reperfusion, Myocardial Infarction
- What is being tested?
- Post-conditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2009to Aug 2012
- 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
- Subject must be at least 18 years of age.
- Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving postconditioning and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure
- Diagnosis of STEMI
- presence of chest pain for more than 30 minutes but less than 12 hours after symptom onset
- ST-segment elevation more than 1 mm in at least 2 contiguous leads
- Angiographic Inclusion Criteria
Show all 15Show fewer
- Target lesion(s) must be located in a native coronary artery
- Target lesion(s) must be amenable for percutaneous coronary intervention
- TIMI flow grade of infarct related arteries <2
- General Exclusion Criteria
- Patients with hemodynamic instability or those with cardiogenic shock
- Target lesion is located in left main stem
- Rescue PCI after thrombolysis or facilitated PCI
- Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment)
- Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Postconditioning On Myocardial Reperfusion in Patients With ST-segment Elevation Myocardial Infarction
The purpose of this study is to investigate the effects of postconditioning on myocardial reperfusion in patients with ST-segment elevation myocardial infarction.
- Conditions
- Myocardial Reperfusion, Myocardial Infarction
- Being tested
- Post-conditioning
- Keywords
- Post-conditioning, ST-elevation myocardial infarction, Angioplasty, Transluminal, Percutaneous Coronary
- Medical subject headings
- Myocardial Infarction, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post-conditioningProcedure or surgery
Coronary angiogram is performed to allow identification of the culprit coronary artery and to check no reperfusion before PCI (TIMI grade <2). Restoration of coronary blood flow can be achieved by thrombus aspiration, balloon angioplasty, direct stenting or together.In the postconditioning group, immediately after restoration (TIMI grade ≥2) of coronary flow (without regard to method of achieving restoration), angioplasty balloon will be positioned at the culprit lesion or stented segment and inflated 4 times for 1 minute with low-pressure (4 to 6 atm) inflations, each separated by 1 minute of reflow. When restoration of coronary flow is achieved by thrombus aspiration or balloon angioplasty and residual stenosis is remained ≥30%, stent will be deployed.
| Study group | Role | What they receive |
|---|---|---|
| Post-conditioning | Experimental | Not described Receives: Procedure: Post-conditioning |
| Conventional primary PCI | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The dichotomous rate of complete ST-segment resolution (STR)
Measured: at 30 minutes after final contrast injection
Secondary outcomes (10)
Myocardial blush grade
Measured: within 10 minutes after PCI
Thrombolysis in Myocardial Infarction (TIMI) flow grade
Measured: within 10 minutes after PCI
Angiographic no-reflow
Measured: during PCI
All death
Measured: at 30 days and 1 year
Stent thrombosis
Measured: at 30 days and 1 year
Cardiac death
Measured: at 30 days and 1 year
Myocardial infarction
Measured: at 30 days and 1 year
Severe heart failure
Severe heart failure was defined as heart failure with documented arterial partial pressure of oxygen less than 60 mmHg or with pulmonary edema documented radiographically or requiring intubation, 100% oxygen, or insertion of a mechanical support device.
Measured: at 30 days and 1 year
Target vessel revascularization (TVR)
Measured: at 30 days and 1 year
Composite of death, MI, severe heart failure, or stent thrombosis
Measured: at 30 days and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Myocardial ReperfusionStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- None (open label)
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyeon-Cheol Gwon, Samsung Medical Center
- Investigators
- Hyeon-Cheol Gwon, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00942500
- Sponsor's protocol ID
- 2009-02-007
- Acronym
- POST
- Status last verified
- Oct 2012
- First submitted
- 13 Jul 2009
- Last updated
- 1 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hahn JY, Yu CW, Park HS, Song YB, Kim EK, Lee HJ, Bae JW, Chung WY, Choi SH, Choi JH, Bae JH, An KJ, Park JS, Oh JH, Kim SW, Hwang JY, Ryu JK, Lim DS, Gwon HC. Long-term effects of ischemic postconditioning on clinical outcomes: 1-year follow-up of the POST randomized trial. Am Heart J. 2015 May;169(5):639-46. doi: 10.1016/j.ahj.2015.01.015. Epub 2015 Feb 27.
PubMed 25965711Kim EK, Hahn JY, Song YB, Lee SC, Choi JH, Choi SH, Lee SH, Choe YH, Gwon HC. Effect of ischemic postconditioning on myocardial salvage in patients undergoing primary percutaneous coronary intervention for ST-segment elevation myocardial infarction: cardiac magnetic resonance substudy of the POST randomized trial. Int J Cardiovasc Imaging. 2015 Mar;31(3):629-37. doi: 10.1007/s10554-015-0589-y. Epub 2015 Jan 15.
PubMed 25589306Hahn JY, Song YB, Kim EK, Yu CW, Bae JW, Chung WY, Choi SH, Choi JH, Bae JH, An KJ, Park JS, Oh JH, Kim SW, Hwang JY, Ryu JK, Park HS, Lim DS, Gwon HC. Ischemic postconditioning during primary percutaneous coronary intervention: the effects of postconditioning on myocardial reperfusion in patients with ST-segment elevation myocardial infarction (POST) randomized trial. Circulation. 2013 Oct 22;128(17):1889-96. doi: 10.1161/CIRCULATIONAHA.113.001690. Epub 2013 Sep 25.
PubMed 24068776
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Postconditioning On Myocardial Reperfusion in Patients With ST-segment Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT00942500
- Acronym / sponsor ID
- POST / 2009-02-007
- Conditions
- Myocardial Reperfusion, Myocardial Infarction
- Keywords
- Post-conditioning, ST-elevation myocardial infarction, Angioplasty, Transluminal, Percutaneous Coronary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 21 Jul 2009 (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 investigate the effects of postconditioning on myocardial reperfusion in patients with ST-segment elevation myocardial infarction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post-conditioning | Experimental | Procedure: Post-conditioning |
| Conventional primary PCI | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Subject must be at least 18 years of age.
- Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving postconditioning and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure
- Diagnosis of STEMI
- Angiographic Inclusion Criteria
- Target lesion(s) must be located in a native coronary artery
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Post-conditioningCoronary angiogram is performed to allow identification of the culprit coronary artery and to check no reperfusion before PCI (TIMI grade <2). Restoration of coronary blood flow can be achieved by thrombus aspiration, balloon angioplasty, direct stenting or together.In the postconditioning group, immediately after restoration (TIMI grade ≥2) of coronary flow (without regard to method of achieving restoration), angioplasty balloon will be positioned at the culprit lesion or stented segment and inflated 4 times for 1 minute with low-pressure (4 to 6 atm) inflations, each separated by 1 minute of reflow. When restoration of coronary flow is achieved by thrombus aspiration or balloon angioplasty and residual stenosis is remained ≥30%, stent will be deployed. | Procedure or surgery | Post-conditioning |
Primary outcome
The dichotomous rate of complete ST-segment resolution (STR)
Time frame: at 30 minutes after final contrast injection
10 secondary outcomes
Myocardial blush grade
Time frame: within 10 minutes after PCI
Thrombolysis in Myocardial Infarction (TIMI) flow grade
Time frame: within 10 minutes after PCI
Angiographic no-reflow
Time frame: during PCI
All death
Time frame: at 30 days and 1 year
Stent thrombosis
Time frame: at 30 days and 1 year
Cardiac death
Time frame: at 30 days and 1 year
Myocardial infarction
Time frame: at 30 days and 1 year
Severe heart failure
Time frame: at 30 days and 1 year
Target vessel revascularization (TVR)
Time frame: at 30 days and 1 year
Composite of death, MI, severe heart failure, or stent thrombosis
Time frame: at 30 days and 1 year
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 1 Nov 2012.
- Derived from this study: PubMed 25965711Hahn JY, Yu CW, Park HS, Song YB, Kim EK, Lee HJ, Bae JW, Chung WY, Choi SH, Choi JH, Bae JH, An KJ, Park JS, Oh JH, Kim SW, Hwang JY, Ryu JK, Lim DS, Gwon HC. Long-term effects of ischemic postconditioning on clinical outcomes: 1-year follow-up of the POST randomized trial. Am Heart J. 2015 May;169(5):639-46. doi: 10.1016/j.ahj.2015.01.015. Epub 2015 Feb 27.
- Derived from this study: PubMed 25589306Kim EK, Hahn JY, Song YB, Lee SC, Choi JH, Choi SH, Lee SH, Choe YH, Gwon HC. Effect of ischemic postconditioning on myocardial salvage in patients undergoing primary percutaneous coronary intervention for ST-segment elevation myocardial infarction: cardiac magnetic resonance substudy of the POST randomized trial. Int J Cardiovasc Imaging. 2015 Mar;31(3):629-37. doi: 10.1007/s10554-015-0589-y. Epub 2015 Jan 15.
- Derived from this study: PubMed 24068776Hahn JY, Song YB, Kim EK, Yu CW, Bae JW, Chung WY, Choi SH, Choi JH, Bae JH, An KJ, Park JS, Oh JH, Kim SW, Hwang JY, Ryu JK, Park HS, Lim DS, Gwon HC. Ischemic postconditioning during primary percutaneous coronary intervention: the effects of postconditioning on myocardial reperfusion in patients with ST-segment elevation myocardial infarction (POST) randomized trial. Circulation. 2013 Oct 22;128(17):1889-96. doi: 10.1161/CIRCULATIONAHA.113.001690. Epub 2013 Sep 25.
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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.
Hyeon-Cheol Gwon, MD, PhD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Post-conditioning in people with Myocardial Reperfusion and Myocardial Infarction, run by Samsung Medical Center 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 15 inclusion and 0 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 1 Nov 2012. 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?
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?
The dichotomous rate of complete ST-segment resolution (STR) (time frame: at 30 minutes after final contrast injection). 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 NCT00942500, which also lists 3 linked publications.
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 Nov 2012.