Ischemia-reperfusion InjuryPhase 2GCT-NR-STEMINCT06552442
Intracoronary Administration of Glucocorticoids as a Treatment Method for No-Glucocorticoid Treatment for No-Reflow in STEMI
A Phase 2 study testing Methylprednisolone in people with Ischemia-reperfusion Injury and No-reflow, run by Amosov National Institute of Cardiovascular Surgery at 1 site in Ukraine.
Trial summary
The goal of this clinical trial is to improve reperfusion therapy in STEMI patients with no-reflow phenomenon. Based on literature review and pathological studies, the investigators believe that myocardial ischemia-reperfusion injury is primarily due to myocardial edema, which is angiographically manifested by the… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Ischemia-reperfusion Injury, No-reflow
- What is being tested?
- Methylprednisolone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUkraine
- Study dates
- 5 Sep 2020to 1 Jun 2024
- Phase
- Phase 2
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- TIMI 0/1 flow after successful artery obstruction stenting
- Men and women aged 40 years and older
Who cannot join
- Coronary artery dissection
- Abrupt intraoperative coronary artery closure
- Intraoperative thrombosis
Trial locations and contacts
1 site in 1 country.
Ukraine1 site
Amosov National Institute of cardiovascular surgery
Kyiv, Amosov Street, 6, 03038
About this study
Official title: Intracoronary Administration of Glucocorticoids as a Treatment Method for No-Reflow Phenomenon in STEMI Patients
The goal of this clinical trial is to improve reperfusion therapy in STEMI patients with no-reflow phenomenon. Based on literature review and pathological studies, the investigators believe that myocardial ischemia-reperfusion injury is primarily due to myocardial edema, which is angiographically manifested by the no-reflow. To restore blood flow, high-dose intracoronary methylprednisolone was applied. The main idea is to stabilize cell membranes and stop the progression of edema. It is local, not systemic, single administration that avoids serious side effects. The primary hypothesis is that hormone administration will improve blood flow to TIMI 2/3 in TIMI 0/1after stenting infarct-related artery.
Read the detailed description
The study involves comparing the main group receiving intracoronary methylprednisolone with a group of patients without intracoronary pharmacotherapy. Preliminary results: the use of methylprednisolone allows for the restoration of coronary blood flow but does not affect mortality.
- Conditions
- Ischemia-reperfusion Injury, No-reflow
- Being tested
- Methylprednisolone
- Keywords
- acute coronary syndrome, STEMI, No-reflow, Intracoronary, Glucocorticoids
- Medical subject headings
- Reperfusion Injury, Acute Coronary Syndrome, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-dose intracoronary glucocorticoid methylprednisolone to abrogate no-reflow: a unique study for restoration of infarct-related artery patency and reduction of ischemia-reperfusion injury
| Study group | Role | What they receive |
|---|---|---|
| Main group | Experimental | Main group - 10 patients. STEMI patients with the occurrence of the no-reflow phenomenon after stenting of the infarct-related artery.
Treatment of the phenomenon: intracoronary administration of methylprednisolone. Receives: Drug: Methylprednisolone |
| Control group | No intervention | Control group - 10 patients. STEMI patients with the occurrence of the no-reflow phenomenon after stenting of the infarct-related artery. Treatment of the phenomenon: no pharmacological intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Restoration of coronary blood flow
Degree of restoration of coronary blood flow on the Thrombolysis in myocardial infarction (ТIMI) grade 0-3 (3 is the best result, 0/1 - bad or no-reflow) from TIMI 0 or TIMI 1 to TIMI 2 or TIMI 3
Measured: 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start5 Sep 2020
- Primary completion1 Jan 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemia-reperfusion InjuryStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The main study group receives intracoronary methylprednisolone for the no-reflow phenomenon. The control group does not receive any pharmacological intervention. Considering that this complication is very rare, the control group was selected retrospectively.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amosov National Institute of Cardiovascular Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06552442
- Sponsor's protocol ID
- Ethics Protocol Number 1/2020
- Acronym
- GCT-NR-STEMI
- Status last verified
- Aug 2024
- First submitted
- 10 Jul 2024
- Last updated
- 14 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracoronary Administration of Glucocorticoids as a Treatment Method for No-Reflow Phenomenon in STEMI Patients
- ClinicalTrials.gov ID
- NCT06552442
- Acronym / sponsor ID
- GCT-NR-STEMI / Ethics Protocol Number 1/2020
- Conditions
- Ischemia-reperfusion Injury, No-reflow
- Keywords
- acute coronary syndrome, STEMI, No-reflow, Intracoronary, Glucocorticoids
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Amosov National Institute of Cardiovascular SurgeryUniversity, hospital or other
- Study start
- 5 Sep 2020 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 14 Aug 2024 (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 goal of this clinical trial is to improve reperfusion therapy in STEMI patients with no-reflow phenomenon. Based on literature review and pathological studies, the investigators believe that myocardial ischemia-reperfusion injury is primarily due to myocardial edema, which is angiographically manifested by the no-reflow. To restore blood flow, high-dose intracoronary methylprednisolone was applied. The main idea is to stabilize cell membranes and stop the progression of edema. It is local, not systemic, single administration that avoids serious side effects. The primary hypothesis is that hormone administration will improve blood flow to TIMI 2/3 in TIMI 0/1after stenting infarct-related artery.
Detailed description
The study involves comparing the main group receiving intracoronary methylprednisolone with a group of patients without intracoronary pharmacotherapy. Preliminary results: the use of methylprednisolone allows for the restoration of coronary blood flow but does not affect mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The main study group receives intracoronary methylprednisolone for the no-reflow phenomenon. The control group does not receive any pharmacological intervention. Considering that this complication is very rare, the control group was selected retrospectively.
| Arm | Type | Receives |
|---|---|---|
| Main group | Experimental | Drug: MethylprednisoloneMain group - 10 patients. STEMI patients with the occurrence of the no-reflow phenomenon after stenting of the infarct-related artery. Treatment of the phenomenon: intracoronary administration of methylprednisolone. |
| Control group | No intervention | –Control group - 10 patients. STEMI patients with the occurrence of the no-reflow phenomenon after stenting of the infarct-related artery. Treatment of the phenomenon: no pharmacological intervention. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- TIMI 0/1 flow after successful artery obstruction stenting
- Men and women aged 40 years and older
Key exclusion criteria (3 listed)
- Coronary artery dissection
- Abrupt intraoperative coronary artery closure
- Intraoperative thrombosis
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 |
|---|---|---|
| MethylprednisoloneHigh-dose intracoronary glucocorticoid methylprednisolone to abrogate no-reflow: a unique study for restoration of infarct-related artery patency and reduction of ischemia-reperfusion injury | Drug | Main group |
Primary outcome
Restoration of coronary blood flow
Time frame: 3 minutes
Degree of restoration of coronary blood flow on the Thrombolysis in myocardial infarction (ТIMI) grade 0-3 (3 is the best result, 0/1 - bad or no-reflow) from TIMI 0 or TIMI 1 to TIMI 2 or TIMI 3
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 14 Aug 2024.
Related trials for Ischemia-reperfusion Injury
Not yet recruiting
New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
Liver Transplantation (LT), Early Allograft Dysfunction
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingPhase 2
Prevention of Reperfusion Injury Outcomes Through Effective Cardioprotection Targeting Myocardial Infarction
Myocardial Infarction, Reperfusion Injury
Recruiting
Rapid Local Ischemic Postconditioning on Stroke After Thrombectomy
Acute Ischemic Stroke
Recruiting
Avoiding Recooling After Normothermic Machine Perfusion in Liver Transplantation
Liver Transplantation (LT), Ischemia-Reperfusion Injury
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Methylprednisolone in people with Ischemia-reperfusion Injury and No-reflow, run by Amosov National Institute of Cardiovascular Surgery at 1 site in Ukraine.
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 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 14 Aug 2024. 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 Ukraine. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Restoration of coronary blood flow (time frame: 3 minutes). 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 14 Aug 2024.