Acute Myocardial Infarction With ST ElevationNCT04824716
Analysis of the Efficacy of Cardiac Ischemic Postconditioning With New Clinical End-points Using Novel Biomarkers
A study testing Postconditioning and Percutaneous coronary intervention in people with Acute Myocardial Infarction With ST Elevation, run by Peter Ferdinandy at 3 sites in Hungary.
Trial summary
The aim of the present study was to investigate the efficacy of ischemic postconditioning in acute myocardial infarction patients. The safety of patients enrolled in the study was ensured during the entire study. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Myocardial Infarction With ST Elevation
- What is being tested?
- Postconditioning and Percutaneous coronary intervention
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesHungary
- Study dates
- 14 Jan 2013to 15 Oct 2018
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must be >18 years of age
- Myocardial infarction with elevated ST
- Chest pain onset less than 12 hours before PCI
- concordant ST elevation (>0,1 mV) in at least 2 ECG leads
- Occluded main proximal or middle main coronary ('Thrombolysis In Myocardial Infarction' flow grade: 0) diagnosed with coronarography
- Coronary opened by PCI (TIMI 2 flow grade)
- Awake, conscious, co-operating patient, who is able to retain his breath for 10 sec
- Signed Patient Information Leaflet and Patient Informed Consent Form
Who cannot join
- Cardiogenic shock
- Previous myocardial infarction in the area of the occluded coronary artery
- Occluded coronary with visible collateral branches
- Lack of co-operation
- Current left or right bundle branch block (LBBB)
- Malignant ventricle arrhythmia or atrial fibrillation
- Killip class > 2
- Known renal failure
Trial locations and contacts
3 sites in 1 country.
Hungary3 sites
Heart and Vascular Center, Semmelweis University
Budapest, H-1122
Pharmahungary Group
Szeged, 6722
Department of Invasive Cardiology of Cardiology Center, Faculty of Medicine, University of Szeged
Szeged, H-6720
About this study
Official title: Evaluation of the Efficacy and Biochemical Characteristics of Ischemic Postconditioning in Patients With Acute Myocardial Infarction Undergoing Percutaneous Coronary Intervention
The aim of the present study was to investigate the efficacy of ischemic postconditioning in acute myocardial infarction patients. The safety of patients enrolled in the study was ensured during the entire study. Over 18 years old men and women were enrolled in the study who arrived to 2 of the most acknowledged Hungarian cardiac centres due to acute myocardial infarction and fulfilled all inclusion and exclusion criteria as per protocol. Patients in the order of their arrival were assigned either to control or post conditioned groups by turns. Medical treatment of the control group was done according to standard Percutaneous Coronary Intervention (PCI) guidelines, i.e. there was no further intervention after artery opening for 8 minutes, then stenting was performed. In the post conditioned group, after reperfusion has been confirmed, the coronary artery was occluded by inflation of the stent balloon 4 times (for 1-1 minute) followed by 1-1-minute reperfusion repeatedly to induce ischemic postconditioning. Postconditioning procedure was followed by stenting as in the control group. All other interventions and treatments in both patient groups were identical according to guidelines.
Read the detailed description
Over 18 years old men and women were enrolled in the study who arrived to 2 of the most acknowledged Hungarian cardiac centres due to acute myocardial infarction and fulfilled all inclusion and exclusion criteria as per protocol. Patients in the order of their arrival were assigned either to control or post conditioned groups by turns. After closing patient enrolment, further subgrouping will be performed in case sufficient group size has been achieved as follows: (1) normal, control, (2) normal, post conditioned, (3) hypercholesterolemic, not treated with statins, control, (4) hypercholesterolemic, not treated with statins, post conditioned, (5) statin treated, control, (6) statin treated, post conditioned.
Characterisation of postconditioning is performed by the following parameters:
- Blood tests 5 minutes before as well as 8, 60 minutes, 24 hours, and 3 months after PCI to measure nitrotyrosine, a biomarker of peroxynitrite formation (nitrosative stress) by ELISA; B-type natriuretic peptide, a biomarker of heart failure by ELISA; matrix metalloproteinase activities (MMP-2 and MMP-9) putative biomarkers of cardiac remodelling by zymography; microRNA expression pattern by sequencing and its validation by quantitative real-time polymerase chain reaction (PCR).
- Routine laboratory tests 6, 12 and 48 hours after PCI including creatine kinase (CKMB) and cardiac troponin T (cTnT).
- ECG immediately after recanalization and intervention after 60 and 90 minutes, then 12, 24, 36 and 48 hours later 12-lead ECG is registered.
- Echocardiography: 48 hours after intervention, standard view to judge left ventricle segments movement disorders
- Angiography: Blush, Syntax score, and ischemic risk zone (area at risk, AAR) are determined
- cardiac late enhancement magnetic resonance (MR) imaging to determine infarct size
At 3-month follow-up visit the following parameters were measured: echocardiography for restitution assessment, cardiac late enhancement MR imaging to determine infarct size and cardiac function, blood sampling for above mentioned biochemical laboratory tests
- Being tested
- Postconditioning, Percutaneous coronary intervention
- Keywords
- ischemic postconditioning, acute myocardial infarction, Investigator Initiated Trial, biomarker, coronary artery disease, ischemic, postconditioning, infarction, infarct size, area at risk, coronary occlusion, balloon catheter, percutaneous coronary intervention, PCI, MRI
- Medical subject headings
- ST Elevation Myocardial Infarction, Coronary Artery Disease, Ischemia, Infarction, Coronary Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PostconditioningProcedure or surgery
The protocol of primary PCI followed by stenting is executed according to the descriptions according to the majority of relevant scientific literature on postconditioning studies and in accordance with the most recent guidelines. In the post conditioned group, after recanalization, the artery is occluded by inflation of stent balloon (4 times for 1-1 minute) followed by 1-1-minute reperfusion, repeatedly. Eight minutes after the start of examination, angiography is made in order to determine blood flow. Intervention is finished by the operator and another angiographic image is made (identical to initial standard projection).
Percutaneous coronary interventionDevice
Percutaneous coronary intervention as per European Society of Cardiology guidelines.
| Study group | Role | What they receive |
|---|---|---|
| postconditioning | Experimental | Patients that underwent postconditioning after primary percutaneous coronary intervention. Receives: Procedure: Postconditioning |
| control | Other | Patients that underwent primary percutaneous coronary intervention. Receives: Device: Percutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac magnetic resonance imaging
Left and right ventricular function, myocardial scar, transmurality, diffusion spectrum imaging (DSI) measurement and evaluation
Measured: 3 months after acute myocardial infarction
Secondary outcomes (8)
Echocardiography measurement of Cardiac Ejection Fraction
Measurement of Cardiac Ejection Fraction using Teicholz and Simpson methods on both study arms.
Measured: 48 hours and 3 months after acute myocardial infarction
Echocardiography measurement of cardiac left ventricular segments for wall motion abnormalities
Calculation of cardiac wall motion score index on both study arms.
Measured: 48 hours and 3 months after acute myocardial infarction
Laboratory measurement of blood Nitrotyrosine levels.
Laboratory measurement of Nitrotyrosine levels in blood samples with ELISA on both study arms.
Measured: 5 minutes before PCI as well as 8 minutes after, 60 minutes, 6, 12, 24, 48 hours, and 3 months after acute myocardial infarction
Laboratory measurement of blood MMP activity.
Laboratory measurement of MMP activity in blood samples with zymography on both study arms.
Measured: 5 minutes before PCI as well as 8 minutes after, 60 minutes, 6, 12, 24, 48 hours, and 3 months after acute myocardial infarction
Laboratory characterization of microRNA patterns with microRNA array
Laboratory characterization of microRNA expression pattern in blood samples with with microRNA array on both study arms.
Measured: 5 minutes before PCI as well as 8 minutes after, 60 minutes, 6, 12, 24, 48 hours, and 3 months after acute myocardial infarction
Validation of selected microRNA with quantitative real-time PCR
Out of the differentially expressed microRNAs identified in Outcome 6, up to 10 different miRNAs will be selected for further validation of their specific expression change (expressed by fold-change) by quantitative real-time PCR in up to 10 randomly selected patients on both study arms, respectively.
Measured: 5 minutes before PCI as well as 8 minutes after, 60 minutes, 6, 12, 24, 48 hours, and 3 months after acute myocardial infarction
Electrocardiography ST segment post-procedure evaluation
Distortion in ST segment amplitude in millivolt (mV) and duration measured in milliseconds (ms) after procedure measured by 12-lead Electrocardiography (ECG) will be evaluated on both study arms.
Measured: Post-procedure 60, 90 minutes, and 12, 24, 48 hours.
Electrocardiography T wave post-procedure evaluation
Distortion in T wave amplitude in millivolt (mV) and duration measured in milliseconds (ms) after procedure measured by 12-lead Electrocardiography (ECG) will be evaluated on both study arms.
Measured: Post-procedure 60, 90 minutes, and 12, 24, 48 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start14 Jan 2013
- Primary completion15 Oct 2018
- Study completion15 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial Infarction With ST ElevationStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peter Ferdinandy
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Semmelweis University Heart and Vascular Center, Szeged University
- Responsible party
- Sponsor-investigator, Peter Ferdinandy, Pharmahungary Group
- Investigators
- Béla Merkely, MD, PhD, Principal investigator, Heart and Vascular Center, Semmelweis University, BudapestPeter Ferdinandy, MD, PhD, MBA, Study director, Pharmahungary GroupImre Ungi, MD, PhD, Principal investigator, University of Szeged, Faculty of Medicine, Cardiology Center, Department of Invasive Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04824716
- Sponsor's protocol ID
- IPOST-01, v2.0, Nov 22, 2012
- Status last verified
- Apr 2021
- First submitted
- 8 Mar 2021
- Last updated
- 21 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Biochemical Characteristics of Ischemic Postconditioning in Patients With Acute Myocardial Infarction Undergoing Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT04824716
- Acronym / sponsor ID
- IPOST-01, v2.0, Nov 22, 2012
- Keywords
- ischemic postconditioning, acute myocardial infarction, Investigator Initiated Trial, biomarker, coronary artery disease, ischemic, postconditioning, infarction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Peter FerdinandyIndustry (pharma, biotech, devices)
- Collaborators
- Semmelweis University Heart and Vascular Center, Szeged University
- Study start
- 14 Jan 2013 (actual)
- Primary completion
- 15 Oct 2018 (actual)
- Study completion
- 15 Oct 2018 (actual)
- First posted
- 1 Apr 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.
The aim of the present study was to investigate the efficacy of ischemic postconditioning in acute myocardial infarction patients. The safety of patients enrolled in the study was ensured during the entire study. Over 18 years old men and women were enrolled in the study who arrived to 2 of the most acknowledged Hungarian cardiac centres due to acute myocardial infarction and fulfilled all inclusion and exclusion criteria as per protocol. Patients in the order of their arrival were assigned either to control or post conditioned groups by turns. Medical treatment of the control group was done according to standard Percutaneous Coronary Intervention (PCI) guidelines, i.e. there was no further intervention after artery opening for 8 minutes, then stenting was performed. In the post conditioned group, after reperfusion has been confirmed, the coronary artery was occluded by inflation of the stent balloon 4 times (for 1-1 minute) followed by 1-1-minute reperfusion repeatedly to induce ischemic postconditioning. Postconditioning procedure was followed by stenting as in the control group. All other interventions and treatments in both patient groups were identical according to guidelines.
Detailed description
Over 18 years old men and women were enrolled in the study who arrived to 2 of the most acknowledged Hungarian cardiac centres due to acute myocardial infarction and fulfilled all inclusion and exclusion criteria as per protocol. Patients in the order of their arrival were assigned either to control or post conditioned groups by turns. After closing patient enrolment, further subgrouping will be performed in case sufficient group size has been achieved as follows: (1) normal, control, (2) normal, post conditioned, (3) hypercholesterolemic, not treated with statins, control, (4) hypercholesterolemic, not treated with statins, post conditioned, (5) statin treated, control, (6) statin treated, post conditioned.
Characterisation of postconditioning is performed by the following parameters:
- Blood tests 5 minutes before as well as 8, 60 minutes, 24 hours, and 3 months after PCI to measure nitrotyrosine, a biomarker of peroxynitrite formation (nitrosative stress) by ELISA; B-type natriuretic peptide, a biomarker of heart failure by ELISA; matrix metalloproteinase activities (MMP-2 and MMP-9) putative biomarkers of cardiac remodelling by zymography; microRNA expression pattern by sequencing and its validation by quantitative real-time polymerase chain reaction (PCR).
- Routine laboratory tests 6, 12 and 48 hours after PCI including creatine kinase (CKMB) and cardiac troponin T (cTnT).
- ECG immediately after recanalization and intervention after 60 and 90 minutes, then 12, 24, 36 and 48 hours later 12-lead ECG is registered.
- Echocardiography: 48 hours after intervention, standard view to judge left ventricle segments movement disorders
- Angiography: Blush, Syntax score, and ischemic risk zone (area at risk, AAR) are determined
- cardiac late enhancement magnetic resonance (MR) imaging to determine infarct size
At 3-month follow-up visit the following parameters were measured: echocardiography for restitution assessment, cardiac late enhancement MR imaging to determine infarct size and cardiac function, blood sampling for above mentioned biochemical laboratory tests
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| postconditioning | Experimental | Procedure: PostconditioningPatients that underwent postconditioning after primary percutaneous coronary intervention. |
| control | Other | Device: Percutaneous coronary interventionPatients that underwent primary percutaneous coronary intervention. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject must be >18 years of age
- Myocardial infarction with elevated ST
- Chest pain onset less than 12 hours before PCI
- concordant ST elevation (>0,1 mV) in at least 2 ECG leads
- Occluded main proximal or middle main coronary ('Thrombolysis In Myocardial Infarction' flow grade: 0) diagnosed with coronarography
Key exclusion criteria (8 listed)
- Cardiogenic shock
- Previous myocardial infarction in the area of the occluded coronary artery
- Occluded coronary with visible collateral branches
- Lack of co-operation
- Current left or right bundle branch block (LBBB)
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 |
|---|---|---|
| PostconditioningThe protocol of primary PCI followed by stenting is executed according to the descriptions according to the majority of relevant scientific literature on postconditioning studies and in accordance with the most recent guidelines. In the post conditioned group, after recanalization, the artery is occluded by inflation of stent balloon (4 times for 1-1 minute) followed by 1-1-minute reperfusion, repeatedly. Eight minutes after the start of examination, angiography is made in order to determine blood flow. Intervention is finished by the operator and another angiographic image is made (identical to initial standard projection). | Procedure or surgery | postconditioning |
| Percutaneous coronary interventionPercutaneous coronary intervention as per European Society of Cardiology guidelines. | Device | control |
Primary outcome
Cardiac magnetic resonance imaging
Time frame: 3 months after acute myocardial infarction
Left and right ventricular function, myocardial scar, transmurality, diffusion spectrum imaging (DSI) measurement and evaluation
8 secondary outcomes
Echocardiography measurement of Cardiac Ejection Fraction
Time frame: 48 hours and 3 months after acute myocardial infarction
Echocardiography measurement of cardiac left ventricular segments for wall motion abnormalities
Time frame: 48 hours and 3 months after acute myocardial infarction
Laboratory measurement of blood Nitrotyrosine levels.
Time frame: 5 minutes before PCI as well as 8 minutes after, 60 minutes, 6, 12, 24, 48 hours, and 3 months after acute myocardial infarction
Laboratory measurement of blood MMP activity.
Time frame: 5 minutes before PCI as well as 8 minutes after, 60 minutes, 6, 12, 24, 48 hours, and 3 months after acute myocardial infarction
Laboratory characterization of microRNA patterns with microRNA array
Time frame: 5 minutes before PCI as well as 8 minutes after, 60 minutes, 6, 12, 24, 48 hours, and 3 months after acute myocardial infarction
Validation of selected microRNA with quantitative real-time PCR
Time frame: 5 minutes before PCI as well as 8 minutes after, 60 minutes, 6, 12, 24, 48 hours, and 3 months after acute myocardial infarction
Electrocardiography ST segment post-procedure evaluation
Time frame: Post-procedure 60, 90 minutes, and 12, 24, 48 hours.
Electrocardiography T wave post-procedure evaluation
Time frame: Post-procedure 60, 90 minutes, and 12, 24, 48 hours.
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 21 Apr 2021.
- Website of Pharmahungary Group.Link provided by the sponsor.
- Website of Semmelweis University Heart and Vascular Center.Link provided by the sponsor.
- Website of Department of Invasive Cardiology of Cardiology Center, Faculty of Medicine, University of Szeged.Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Acute Myocardial Infarction With ST Elevation
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
RecruitingPhase 2
Prevention of Reperfusion Injury Outcomes Through Effective Cardioprotection Targeting Myocardial Infarction
Myocardial Infarction, Reperfusion Injury
Not yet recruitingObservational study
Incremental Prognostic Utility of CBC-derived Inflammatory Indices After Incomplete Coronary Revascularization: Association With 12-months Cardiovascular Outcomes
STEMI, High Risk NSTEMI
RecruitingObservational study
SuperSaturated Oxygen Comprehensive Observational Registry
STEMI - ST Elevation Myocardial Infarction, AMI
RecruitingPhase 4
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
ST Elevation Myocardial Infarction
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.
Béla Merkely, MD, PhD principal investigator
Heart and Vascular Center, Semmelweis University, Budapest
Peter Ferdinandy, MD, PhD, MBA study director
Pharmahungary Group
Imre Ungi, MD, PhD principal investigator
University of Szeged, Faculty of Medicine, Cardiology Center, Department of Invasive Cardiology
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postconditioning and Percutaneous coronary intervention in people with Acute Myocardial Infarction With ST Elevation, run by Peter Ferdinandy at 3 sites in Hungary.
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 8 inclusion and 8 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 21 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Hungary. 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?
Cardiac magnetic resonance imaging (time frame: 3 months after acute myocardial infarction). 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 21 Apr 2021.