STEMIOxiSTEMIhFABPNCT04034940
Correlations Between Oxidative Stress Biomarkers, h-FABP and Left Ventricular Dysfunction in Patients With Acute Myocardial Infarction Undergoing Primary PCI
A study testing Dosing Oxidative stress biomarkers & hFABP in STEMI pPCI patients in people with STEMI and Oxidative Stress, run by Grigore T. Popa University of Medicine and Pharmacy at 1 site in Romania.
Trial summary
The investigators intend to evaluate Oxidative Stress biomarkers through a. Catalase Activity Assay; b. Lipid Peroxidation Assay; c. SOD Assay; d. Total Antioxidant Capacity Assay; e. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- STEMI, Oxidative Stress, Oxidative Stress Induction
- What is being tested?
- Dosing Oxidative stress biomarkers & hFABP in STEMI pPCI patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteRomania
- Study dates
- Aug 2019to Aug 2020
- 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
- Adults with ST elevation Myocardial Infarction (<12h) diagnostic confirmed;
- Included in the Romanian National Programme of Primary Percutaneous Revascularisation (for who the Guidelines recommend primary PCI);
Who cannot join
- Patients who do not sign informed consent for primary PCI
Trial locations and contacts
1 site in 1 country.
Romania1 site, 1 recruiting
- Recruiting
Cardiovascular Diseases Institute Iasi
Iași, Iaşi, 700503
Alexandru Burlacu, MD, PhD, 0040744488580, alburlacu@yahoo.com
About this study
The investigators intend to evaluate Oxidative Stress biomarkers through a. Catalase Activity Assay; b. Lipid Peroxidation Assay; c. SOD Assay; d. Total Antioxidant Capacity Assay; e. Glutathione Peroxidase at patients with acute myocardial infarction STEMI referred for primary PCI; The investigators also aim to evaluate cardiac necrosis by measuring Heart Fatty Acid Binding Protein (H-FABP), TnI, CK, CK-MB, LDH and AST in these patients with acute myocardial infarction referred for primary PCI; Also, the investigators intend to evaluate body composition through bioimpedance spectroscopy (BCM - Fresenius Care) at the moment of admission.
The investigators aim to fully characterise these patients through oxidative millieu, hFABP and make correlations with LVEF dysfunction.
Read the detailed description
Gathered data:
- Descriptive general demographic data;
- Previous pathologies (ischemic heart disease, peripheral arterial disease, stroke, heart failure, previous percutaneous coronary interventions, coronary artery bypass grafting - CABG, known renal disease);
- Cardiovascular risk factors (age, weight, height, abdominal perimeter, body mass index, smoking, sedentariness, diabetes, hypertension, dyslipidaemia);
- Oxidative Stress biomarkers: Catalase Activity Assay; Lipid Peroxidation Assay; SOD Assay; Total Antioxidant Capacity Assay; Glutathione ;
- Cardiac necrosis markers: Heart Fatty Acid Binding Protein (H-FABP), TnI, CK, CK-MB, LDH and OGT;
- Routine biological data;
- Metabolic data (obtained from two body composition monitoring evaluations - before and 12 hours after coronary intervention) - body water, body fat tissue;
- Information regarding primary PCI (less than 12 hours of ischemic symptoms);
- Coronarographic details, type of used stent, periprocedural specific complications, final TIMI - thrombolysis in myocardial infarction - flow);
- Echocardiography at admission (LVEF);
- Measurement of arterial stiffness through Sphigmocore pulsed-wave-velocity (24 hrs post-procedural, 2 velocities: carotid - femoral and carotid - radial);
- Calculating of cardiovascular risk scores: Syntax Score, Framingham score, ASSIGN score, QRISK2 score, PROCAM score, CRUSADE score, GRACE score, CHADS VASc score, MESA score, ASCVD score, Hamilton Depression Rating Scale (HAM-D), Hamilton Rating Scale for Anxiety;
- In-hospital and one month follow-up MACE.
- Conditions
- STEMI, Oxidative Stress, Oxidative Stress Induction, Primary PCI, hFABP, Left Ventricular Dysfunction
- Being tested
- Dosing Oxidative stress biomarkers & hFABP in STEMI pPCI patients
- Medical subject headings
- ST Elevation Myocardial Infarction, Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dosing Oxidative stress biomarkers & hFABP in STEMI pPCI patientsOther
Dosing oxidative stress biomarkers and hFABP in STEMI pPCI
| Study group | Role | What they receive |
|---|---|---|
| primary PCI STEMI patients | Other | All Patients with AMI refered for primary PCI in single center Receives: Other: Dosing Oxidative stress biomarkers & hFABP in STEMI pPCI patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxidative Stress status in Acute Myocardial Infarction Patients undergoing primary PCI
Assessment of oxidative stress status by measuring Catalase Activity Assay; Lipid Peroxidation Assay; SOD Assay; Total Antioxidant Capacity Assay; Glutathione Peroxidase.
Measured: 1 year
2. Cardiac necrosis status in Acute Myocardial Infarction Patients undergoing primary PCI.
Assessment of cardiac necrosis by measuring Heart Fatty Acid Binding Protein (H-FABP), TnI, CK, CK-MB, LDH and AST
Measured: 1 year
Secondary outcomes (1)
Hydation Status in Acute Myocardial Infarction Patients undergoing primary PCI.
Assessment of hydration status through body composition monitoring BCM.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study startAug 2019 (estimated)
- Primary completionJul 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for STEMIStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grigore T. Popa University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Collaborators
- Cardiovascular Diseases Institute IASI, Romania
- Responsible party
- Principal investigator, Professor Adrian Covic, Grigore T. Popa University of Medicine and Pharmacy
- Investigators
- Adrian Covic, Professor, Principal investigator, University of Medicine and Pharmacy "Gr. T. Popa" Iasi, Romania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04034940
- Sponsor's protocol ID
- OxiSTEMI01
- Acronym
- OxiSTEMIhFABP
- Status last verified
- Jul 2019
- First submitted
- 24 Jul 2019
- Last updated
- 30 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlations Between Oxidative Stress Biomarkers, h-FABP and Left Ventricular Dysfunction in Patients With Acute Myocardial Infarction Undergoing Primary PCI
- ClinicalTrials.gov ID
- NCT04034940
- Acronym / sponsor ID
- OxiSTEMIhFABP / OxiSTEMI01
- Conditions
- STEMI, Oxidative Stress, Oxidative Stress Induction, Primary PCI, hFABP, Left Ventricular Dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Grigore T. Popa University of Medicine and PharmacyUniversity, hospital or other
- Collaborators
- Cardiovascular Diseases Institute IASI, Romania
- Study start
- Aug 2019 (estimated)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 29 Jul 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.
The investigators intend to evaluate Oxidative Stress biomarkers through a. Catalase Activity Assay; b. Lipid Peroxidation Assay; c. SOD Assay; d. Total Antioxidant Capacity Assay; e. Glutathione Peroxidase at patients with acute myocardial infarction STEMI referred for primary PCI; The investigators also aim to evaluate cardiac necrosis by measuring Heart Fatty Acid Binding Protein (H-FABP), TnI, CK, CK-MB, LDH and AST in these patients with acute myocardial infarction referred for primary PCI; Also, the investigators intend to evaluate body composition through bioimpedance spectroscopy (BCM - Fresenius Care) at the moment of admission.
The investigators aim to fully characterise these patients through oxidative millieu, hFABP and make correlations with LVEF dysfunction.
Detailed description
Gathered data:
- Descriptive general demographic data;
- Previous pathologies (ischemic heart disease, peripheral arterial disease, stroke, heart failure, previous percutaneous coronary interventions, coronary artery bypass grafting - CABG, known renal disease);
- Cardiovascular risk factors (age, weight, height, abdominal perimeter, body mass index, smoking, sedentariness, diabetes, hypertension, dyslipidaemia);
- Oxidative Stress biomarkers: Catalase Activity Assay; Lipid Peroxidation Assay; SOD Assay; Total Antioxidant Capacity Assay; Glutathione ;
- Cardiac necrosis markers: Heart Fatty Acid Binding Protein (H-FABP), TnI, CK, CK-MB, LDH and OGT;
- Routine biological data;
- Metabolic data (obtained from two body composition monitoring evaluations - before and 12 hours after coronary intervention) - body water, body fat tissue;
- Information regarding primary PCI (less than 12 hours of ischemic symptoms);
- Coronarographic details, type of used stent, periprocedural specific complications, final TIMI - thrombolysis in myocardial infarction - flow);
- Echocardiography at admission (LVEF);
- Measurement of arterial stiffness through Sphigmocore pulsed-wave-velocity (24 hrs post-procedural, 2 velocities: carotid - femoral and carotid - radial);
- Calculating of cardiovascular risk scores: Syntax Score, Framingham score, ASSIGN score, QRISK2 score, PROCAM score, CRUSADE score, GRACE score, CHADS VASc score, MESA score, ASCVD score, Hamilton Depression Rating Scale (HAM-D), Hamilton Rating Scale for Anxiety;
- In-hospital and one month follow-up MACE.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| primary PCI STEMI patients | Other | Other: Dosing Oxidative stress biomarkers & hFABP in STEMI pPCI patientsAll Patients with AMI refered for primary PCI in single center |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults with ST elevation Myocardial Infarction (<12h) diagnostic confirmed;
- Included in the Romanian National Programme of Primary Percutaneous Revascularisation (for who the Guidelines recommend primary PCI);
Key exclusion criteria (1 listed)
- Patients who do not sign informed consent for primary PCI
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 |
|---|---|---|
| Dosing Oxidative stress biomarkers & hFABP in STEMI pPCI patientsDosing oxidative stress biomarkers and hFABP in STEMI pPCI | Other | primary PCI STEMI patients |
Primary outcome
Oxidative Stress status in Acute Myocardial Infarction Patients undergoing primary PCI
Time frame: 1 year
Assessment of oxidative stress status by measuring Catalase Activity Assay; Lipid Peroxidation Assay; SOD Assay; Total Antioxidant Capacity Assay; Glutathione Peroxidase.
2. Cardiac necrosis status in Acute Myocardial Infarction Patients undergoing primary PCI.
Time frame: 1 year
Assessment of cardiac necrosis by measuring Heart Fatty Acid Binding Protein (H-FABP), TnI, CK, CK-MB, LDH and AST
1 secondary outcome
Hydation Status in Acute Myocardial Infarction Patients undergoing primary PCI.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
Related trials for STEMI
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.
Adrian Covic, Professor principal investigator
University of Medicine and Pharmacy "Gr. T. Popa" Iasi, Romania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dosing Oxidative stress biomarkers & hFABP in STEMI pPCI patients in people with STEMI and Oxidative Stress, run by Grigore T. Popa University of Medicine and Pharmacy at 1 site in Romania.
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 1 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 30 Jul 2019. 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 Romania. 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 Razan Al Namat, MD, PhD stud (0040757205114, dr.razan_romania@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxidative Stress status in Acute Myocardial Infarction Patients undergoing primary PCI (time frame: 1 year). The study lists 2 primary outcomes in all. 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 30 Jul 2019.