ST Elevation Myocardial InfarctionNCT04068116
Impact of Ischemic Post-conditioning
A study testing Primary per-cutaneous coronary intervention in people with ST Elevation Myocardial Infarction and Ventricular Remodeling, run by Assiut University.
Trial summary
Study will investigate \& compare the left ventricular remodeling \& systolic function between two groups of ST-elevation myocardial infarction undergoing primary per-cutaneous coronary intervention applying ischemic post-conditioning to one of them. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST Elevation Myocardial Infarction, Ventricular Remodeling, Ventricular Dysfunction
- What is being tested?
- Primary per-cutaneous coronary intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2019to 15 Oct 2021
- 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
- Patients presenting with symptoms of acute myocardial ischemia with time of symptom onset < 12 hours \& meeting the other following criteria of type 1 myocardial infarction according to the fouth universal definition of myocardial infarction(Thygesen, 2019):
- Detection of a rise and/or fall of cardiac troponin values with at least one value above the 99th percentile upper reference limit.(URL)
- Ischemic ECG changes; New or persistent ST-segment elevation with development of pathological Q waves
- Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a pattern consistent with an ischemic etiology.
- Patients undergoing primary percutaneous coronary intervention as the first choice of revascularization therapy.
Who cannot join
- Patients with transient ST segment elevation in the surface electrocardiography.
- Patients presenting within > 12 hours from the onset of maximal symptoms.
- Patients with evidence of pre-infarction angina.
- Patients with evidence of collateral blood flow to the infarct region on their angiogram.
- Patients with history of old myocardial infarction causing chronic impairment of LV systolic function.
- Patients presenting with ST-segment elevation myocardial infarction other than type 1 according to the fouth universal definition of myocardial infarction
About this study
Official title: Impact of Ischemic Post-conditioning During Primary Percutaneous Coronary Intervention on Left Ventricular Remodeling and Global Systolic Function in Patients Presenting With ST-Elevation Myocardial Infarction
Study will investigate \& compare the left ventricular remodeling \& systolic function between two groups of ST-elevation myocardial infarction undergoing primary per-cutaneous coronary intervention applying ischemic post-conditioning to one of them.
Read the detailed description
Among re-perfusion strategies for the management of ST-elevation myocardial infarction , primary per-cutaneous coronary intervention is the preferred one within 120 minutes from the first medical contact.However , restoration of the coronary blood flow can paradoxically reduce the beneficial effects of myocardial re-perfusion , a phenomenon known as myocardial re-perfusion injury.Ischemic post-conditioning has been described as a measure for myocardial salvage , performed by making cycles of briefly interrupted perfusion during the early moments of coronary re-flow.Post-conditioning may be performed immediately after the early re-flow by creating cycles of interrupted inflation \& deflation of the angioplasty balloon in patients undergoing primary per-cutaneous coronary intervention.In this study investigators aim to compare the left ventricular remodeling and global systolic function immediately \& 6 months after re-perfusion between two groups of 100 patients presenting with acute ST-elevation myocardial infarction, using ischemic post-conditioning in one group of patients undergoing primary per-cutaneous coronary intervention (n=50 patients) by making 4 cycles of repeated occlusion \& re-perfusion 30-second each by inflation/deflation of an appropriately sized per-cutaneous trans-luminal coronary angioplasty balloon.The other group will be investigated after re-perfusion by primary per-cutaneous coronary intervention without ischemic post-conditioning (n=50 patients)
- Conditions
- ST Elevation Myocardial Infarction, Ventricular Remodeling, Ventricular Dysfunction, Ischemic Reperfusion Injury
- Being tested
- Primary per-cutaneous coronary intervention
- Medical subject headings
- ST Elevation Myocardial Infarction, Ventricular Remodeling, Ventricular Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary per-cutaneous coronary interventionProcedure or surgery
Patients presenting with ST-elevation myocardial infarction will undergo primary per-cutaneous coronary intervention including balloon angioplasty \& coronary stent deployment as needed +/- post-conditioning (for post-conditioning arm) making 4 cycles of repeated occlusion \& reperfusion 30-second each by inflation/deflation of an appropriately sized PTCA (percutaneous transluminal coronary angioplasty) balloon
| Study group | Role | What they receive |
|---|---|---|
| Postconditioning in primary percutaneous coronary intervention | Experimental | Patients presenting with ST-elevation myocardial infarction will undergo primary per-cutaneous coronary intervention with post-conditioning by making 4 cycles of repeated occlusion \& re-perfusion 30-second each by inflation/deflation of an appropriately sized PTCA (per-cutaneous trans-luminal coronary angioplasty) balloon Receives: Procedure: Primary per-cutaneous coronary intervention |
| Primary percutaneous coronary intervention | Active comparator | Patients presenting with ST-elevation myocardial infarction will undergo primary per-cutaneous coronary intervention without post-conditioning Receives: Procedure: Primary per-cutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular remodeling
percentage of increase in left ventricular end-diastolic volume (EDV) and/or left ventricular end-systolic volume (ESV)
Measured: Immediate-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start15 Oct 2019 (estimated)
- Primary completion15 Oct 2020 (estimated)
- Study completion15 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Fathi Ahmad, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04068116
- Sponsor's protocol ID
- P1
- Status last verified
- Sep 2019
- First submitted
- 20 Aug 2019
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Ischemic Post-conditioning During Primary Percutaneous Coronary Intervention on Left Ventricular Remodeling and Global Systolic Function in Patients Presenting With ST-Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT04068116
- Acronym / sponsor ID
- P1
- Conditions
- ST Elevation Myocardial Infarction, Ventricular Remodeling, Ventricular Dysfunction, Ischemic Reperfusion Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Oct 2019 (estimated)
- Primary completion
- 15 Oct 2020 (estimated)
- Study completion
- 15 Oct 2021 (estimated)
- First posted
- 28 Aug 2019 (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.
Study will investigate \& compare the left ventricular remodeling \& systolic function between two groups of ST-elevation myocardial infarction undergoing primary per-cutaneous coronary intervention applying ischemic post-conditioning to one of them.
Detailed description
Among re-perfusion strategies for the management of ST-elevation myocardial infarction , primary per-cutaneous coronary intervention is the preferred one within 120 minutes from the first medical contact.However , restoration of the coronary blood flow can paradoxically reduce the beneficial effects of myocardial re-perfusion , a phenomenon known as myocardial re-perfusion injury.Ischemic post-conditioning has been described as a measure for myocardial salvage , performed by making cycles of briefly interrupted perfusion during the early moments of coronary re-flow.Post-conditioning may be performed immediately after the early re-flow by creating cycles of interrupted inflation \& deflation of the angioplasty balloon in patients undergoing primary per-cutaneous coronary intervention.In this study investigators aim to compare the left ventricular remodeling and global systolic function immediately \& 6 months after re-perfusion between two groups of 100 patients presenting with acute ST-elevation myocardial infarction, using ischemic post-conditioning in one group of patients undergoing primary per-cutaneous coronary intervention (n=50 patients) by making 4 cycles of repeated occlusion \& re-perfusion 30-second each by inflation/deflation of an appropriately sized per-cutaneous trans-luminal coronary angioplasty balloon.The other group will be investigated after re-perfusion by primary per-cutaneous coronary intervention without ischemic post-conditioning (n=50 patients)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postconditioning in primary percutaneous coronary intervention | Experimental | Procedure: Primary per-cutaneous coronary interventionPatients presenting with ST-elevation myocardial infarction will undergo primary per-cutaneous coronary intervention with post-conditioning by making 4 cycles of repeated occlusion \& re-perfusion 30-second each by inflation/deflation of an appropriately sized PTCA (per-cutaneous trans-luminal coronary angioplasty) balloon |
| Primary percutaneous coronary intervention | Active comparator | Procedure: Primary per-cutaneous coronary interventionPatients presenting with ST-elevation myocardial infarction will undergo primary per-cutaneous coronary intervention without post-conditioning |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients presenting with symptoms of acute myocardial ischemia with time of symptom onset < 12 hours \& meeting the other following criteria of type 1 myocardial infarction according to the fouth universal definition of myocardial infarction(Thygesen, 2019):
- Patients undergoing primary percutaneous coronary intervention as the first choice of revascularization therapy.
Key exclusion criteria (6 listed)
- Patients with transient ST segment elevation in the surface electrocardiography.
- Patients presenting within > 12 hours from the onset of maximal symptoms.
- Patients with evidence of pre-infarction angina.
- Patients with evidence of collateral blood flow to the infarct region on their angiogram.
- Patients with history of old myocardial infarction causing chronic impairment of LV systolic function.
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 |
|---|---|---|
| Primary per-cutaneous coronary interventionPatients presenting with ST-elevation myocardial infarction will undergo primary per-cutaneous coronary intervention including balloon angioplasty \& coronary stent deployment as needed +/- post-conditioning (for post-conditioning arm) making 4 cycles of repeated occlusion \& reperfusion 30-second each by inflation/deflation of an appropriately sized PTCA (percutaneous transluminal coronary angioplasty) balloon | Procedure or surgery | Postconditioning in primary percutaneous coronary intervention, Primary percutaneous coronary intervention |
Primary outcome
Left ventricular remodeling
Time frame: Immediate-6 months
percentage of increase in left ventricular end-diastolic volume (EDV) and/or left ventricular end-systolic volume (ESV)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
Related trials for ST Elevation Myocardial Infarction
RecruitingObservational study
Breisgau PHENO-HEART MI
Myocardial Infarction, STEMI
Recruiting
Reducing Slow/No-Reflow With Prophylactic High-Dose Intracoronary Adenosine Protocol in ST-Elevation Myocardial Infarction The REFLOW AMI Trial
ST-Elevation Myocardial Infarction (STEMI)
Not yet recruitingPhase 2
Evaluating SGLT2 Inhibitors for the Reduction of No-Reflow Phenomenon in Patients Undergoing PCI
No Reflow Phenomenon, Reperfusion Injuries, Myocardial
Recruiting
Optimal Timing of Staged Complete Revascularization in STEMI With Multivessel Disease (OPTION-STEMI2)
Myocardial Infarction (MI)
RecruitingObservational study
Integrated Assessment of Immune-Inflammatory and Metabolic Biomarkers for Prediction of Coronary No-Reflow Following Primary PCI in STEMI Patients
Integrated Assessment, Immune-Inflammatory
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?
A study testing Primary per-cutaneous coronary intervention in people with ST Elevation Myocardial Infarction and Ventricular Remodeling, run by Assiut University.
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 5 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: status not confirmed, as of the sponsor's last update on 6 Sep 2019. 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?
Results are not available in the source record.
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?
Left ventricular remodeling (time frame: Immediate-6 months). 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 6 Sep 2019.