Myocardial InfarctionHeaRt-V-AMINCT05098977
The Usefulness of Assessing Heart Rate Variability in Patients With Acute Myocardial Infarction
An observational study of Myocardial Infarction and Autonomic Dysfunction, run by Grigore T. Popa University of Medicine and Pharmacy at 1 site in Romania.
Trial summary
Aims heart rate variability (HRV) assessment in patients with acute myocardial infarction who undergo primary percutaneous coronary intervention (PCI); measurement of HRV using a device approved for medical use in Europe; assessment of the correlation between HRV and short- and long-term adverse cardiovascular events… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Autonomic Dysfunction
- What is being tested?
- Heart rate variability measurement and Percutaneous coronary intervention
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteRomania
- Study dates
- Nov 2021to Oct 2024
- Phase
- Observational
- 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
Study population: Patients with STEMI referred to catheterization laboratory from Institute of Cardiovascular Diseases "Prof. George IM Georgescu", Iasi, within 12 hours from symptoms onset.
Who may be able to join
- patients with ST-Elevation Myocardial Infarction (STEMI) treated with primary PCI within 12 hours from symptoms onset;
- patients in sinus rhythm;
- patients who have read and signed the standard informed consent regarding enrolment in the study.
Who cannot join
- unconscious or intubated patients who are unable to sign the standard informed consent;
- patients with atrial fibrillation;
- patients with sinus node dysfunction or atrioventricular block of any degree;
- frequent premature supraventricular or ventricular contractions;
- paced ventricular rhythm;
- patients treated with positive inotropic and chronotropic drugs;
- history of myocardial infarction or myocardial revascularization (PCI or CABG);
- patients refusal.
Trial locations and contacts
1 site in 1 country.
Romania1 site
Department of Interventional Cardiology, Institute of Cardiovascular Diseases "Prof. George IM Georgescu" Iasi
Iași, 700503
Crischentian Brinza, MD, +40758431764, crischentian.brinza@d.umfiasi.ro
Adrian Covic, Professor
About this study
Official title: The Usefulness of Assessing Heart Rate Variability in Patients With Acute Myocardial Infarction: From Primary Angioplasty to Secondary Long-term Prevention - a Single Centre, Prospective, Observational Cohort Study
Aims
- heart rate variability (HRV) assessment in patients with acute myocardial infarction who undergo primary percutaneous coronary intervention (PCI);
- measurement of HRV using a device approved for medical use in Europe;
- assessment of the correlation between HRV and short- and long-term adverse cardiovascular events (composite of all-cause mortality and major adverse cardiovascular events - MACE; ventricular arrhythmias; hospital admissions for heart failure; left ventricular systolic and diastolic disfunction; MACE in special subgroups of patients - elderly, diabetes mellitus, chronic kidney disease) in patients treated by primary PCI for acute myocardial infarction;
- creating a registry of HRV parameters measured in a contemporary cohort of patients with acute myocardial infarction.
Read the detailed description
The following data will be collected:
- general demographic data;
- time from chest pain onset to primary PCI;
- comorbidities (ischemic heart disease, arterial hypertension, previous PCI or coronary artery bypass surgery - CABG, heart failure, peripheral artery disease, atrial fibrillation, stroke, diabetes mellitus, kidney disease);
- cardiovascular risk factors (age, body mass index, smoking, abdominal perimeter, sedentarism, gender, inflammation);
- cardiac rhythm derived from electrocardiographic data;
- HRV time- and frequency domain parameters (respectively, SDNN, SDANN, RMSSD and LF, HF, LF/HF ratio);
- routine biological data and biomarkers, including creatine kinase-MB (CK-MB), aspartate transaminase (AST), lactate dehydrogenase (LDH) and cardiac-specific troponin;
- left ventricular ejection fraction at admission, at discharge and at follow-up (1 month, 6 months and 1 year);
- initial and final thrombolysis in myocardial infarction (TIMI) flow;
- type of stent used for coronary angioplasty;
- Global Registry of Acute Coronary Events (GRACE) score;
- SYNTAX score II in case of three-vessel coronary disease or involving left main stem;
- in-hospital, one month and long-term clinical outcomes (composite of all-cause mortality and major adverse cardiovascular events - MACE; ventricular arrhythmias; hospital admissions for heart failure; left ventricular systolic and diastolic disfunction; MACE in special subgroups of patients - elderly, diabetes mellitus, chronic kidney disease).
- Conditions
- Myocardial Infarction, Autonomic Dysfunction
- Being tested
- Heart rate variability measurement, Percutaneous coronary intervention
- Keywords
- Heart rate variability, Percutaneous coronary intervention, Drug-eluting stents, Risk assessment, Prognosis, Major adverse cardiovascular events, Left ventricular ejection fraction, Secondary prevention
- Medical subject headings
- Myocardial Infarction, Primary Dysautonomias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart rate variability measurementProcedure or surgery
HRV will be measured at the moment of patients' admission to the cardiac catheterization laboratory on the top of therapy guided by European guidelines. Both, time- and frequency-domain parameters (respectively, SDNN, SDANN, RMSSD and LF, HF, LF/HF ratio) of the HRV will be obtained using a validated medical device during 5-minute segments before and after revascularization of the culprit artery. In addition, HRV will be evaluated in ambulatory setting, at 1 month and at 6 months after the index event. Obtained interbeat interval data will be further analysed using a dedicated software in order to derive specified HRV parameters.
Percutaneous coronary interventionProcedure or surgery
Also called PCI
Coronary angiography and PCI will be performed using femoral or radial approach after local anesthetic infiltration with Lidocaine and arterial sheath placement. Following the culprit lesion detection and guidewire placement, thromboaspiration and glycoprotein IIb/IIIa inhibitors will be left to the operator decision. Also, the choice of coronary stenting technique and stent sizing will be performed according to the operator experience. Antiplatelet and anticoagulant drugs will be administered in concordance with latest European guidelines.
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of all-cause mortality and major adverse cardiovascular events (MACE)
MACE will be defined as cardiac mortality, fatal and non-fatal myocardial infarction, unplanned target vessel revascularization and stroke)
Measured: in-hospital, 1 month and 1 year
Secondary outcomes (6)
All-cause mortality
Defined as total number of deaths from any cause
Measured: in-hospital, 1 month and 1 year
Cardiac mortality
Defined as number of deaths due to cardiac causes
Measured: in-hospital, 1 month and 1 year
Fatal and non-fatal myocardial infarction
Defined as a new myocardial infarction
Measured: in-hospital, 1 month and 1 year
Target vessel revascularization
Defined as unplanned PCI or coronary artery bypass graft surgery for a stenosis in another part of the vessel treated at the index PCI
Measured: in-hospital, 1 month and 1 year
Target lesion revascularization
Defined as repeat PCI or coronary artery bypass graft surgery of the target lesion treated at the index PCI
Measured: in-hospital, 1 month and 1 year
Stroke
Defined as ischemic or hemorrhagic stroke
Measured: in-hospital, 1 month 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 posted29 Oct 2021
- Study startNov 2021 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grigore T. Popa University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Adrian Covic, Grigore T. Popa University of Medicine and Pharmacy
- Investigators
- Adrian Covic, Professor, Study chair, Gr T Popa University of Medicine and Pharmacy Iasi ROMANIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05098977
- Sponsor's protocol ID
- HeaRt-V-AMI
- Acronym
- HeaRt-V-AMI
- Status last verified
- Oct 2021
- First submitted
- 18 Oct 2021
- Last updated
- 5 Nov 2021
- 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 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Usefulness of Assessing Heart Rate Variability in Patients With Acute Myocardial Infarction: From Primary Angioplasty to Secondary Long-term Prevention - a Single Centre, Prospective, Observational Cohort Study
- ClinicalTrials.gov ID
- NCT05098977
- Acronym / sponsor ID
- HeaRt-V-AMI / HeaRt-V-AMI
- Conditions
- Myocardial Infarction, Autonomic Dysfunction
- Keywords
- Heart rate variability, Percutaneous coronary intervention, Drug-eluting stents, Risk assessment, Prognosis, Major adverse cardiovascular events, Left ventricular ejection fraction, Secondary prevention
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Grigore T. Popa University of Medicine and PharmacyUniversity, hospital or other
- Study start
- Nov 2021 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 29 Oct 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.
Aims
- heart rate variability (HRV) assessment in patients with acute myocardial infarction who undergo primary percutaneous coronary intervention (PCI);
- measurement of HRV using a device approved for medical use in Europe;
- assessment of the correlation between HRV and short- and long-term adverse cardiovascular events (composite of all-cause mortality and major adverse cardiovascular events - MACE; ventricular arrhythmias; hospital admissions for heart failure; left ventricular systolic and diastolic disfunction; MACE in special subgroups of patients - elderly, diabetes mellitus, chronic kidney disease) in patients treated by primary PCI for acute myocardial infarction;
- creating a registry of HRV parameters measured in a contemporary cohort of patients with acute myocardial infarction.
Detailed description
The following data will be collected:
- general demographic data;
- time from chest pain onset to primary PCI;
- comorbidities (ischemic heart disease, arterial hypertension, previous PCI or coronary artery bypass surgery - CABG, heart failure, peripheral artery disease, atrial fibrillation, stroke, diabetes mellitus, kidney disease);
- cardiovascular risk factors (age, body mass index, smoking, abdominal perimeter, sedentarism, gender, inflammation);
- cardiac rhythm derived from electrocardiographic data;
- HRV time- and frequency domain parameters (respectively, SDNN, SDANN, RMSSD and LF, HF, LF/HF ratio);
- routine biological data and biomarkers, including creatine kinase-MB (CK-MB), aspartate transaminase (AST), lactate dehydrogenase (LDH) and cardiac-specific troponin;
- left ventricular ejection fraction at admission, at discharge and at follow-up (1 month, 6 months and 1 year);
- initial and final thrombolysis in myocardial infarction (TIMI) flow;
- type of stent used for coronary angioplasty;
- Global Registry of Acute Coronary Events (GRACE) score;
- SYNTAX score II in case of three-vessel coronary disease or involving left main stem;
- in-hospital, one month and long-term clinical outcomes (composite of all-cause mortality and major adverse cardiovascular events - MACE; ventricular arrhythmias; hospital admissions for heart failure; left ventricular systolic and diastolic disfunction; MACE in special subgroups of patients - elderly, diabetes mellitus, chronic kidney disease).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with STEMI referred to catheterization laboratory from Institute of Cardiovascular Diseases "Prof. George IM Georgescu", Iasi, within 12 hours from symptoms onset.
Key inclusion criteria (3 listed)
- patients with ST-Elevation Myocardial Infarction (STEMI) treated with primary PCI within 12 hours from symptoms onset;
- patients in sinus rhythm;
- patients who have read and signed the standard informed consent regarding enrolment in the study.
Key exclusion criteria (8 listed)
- unconscious or intubated patients who are unable to sign the standard informed consent;
- patients with atrial fibrillation;
- patients with sinus node dysfunction or atrioventricular block of any degree;
- frequent premature supraventricular or ventricular contractions;
- paced ventricular rhythm;
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 |
|---|---|---|
| Heart rate variability measurementHRV will be measured at the moment of patients' admission to the cardiac catheterization laboratory on the top of therapy guided by European guidelines. Both, time- and frequency-domain parameters (respectively, SDNN, SDANN, RMSSD and LF, HF, LF/HF ratio) of the HRV will be obtained using a validated medical device during 5-minute segments before and after revascularization of the culprit artery. In addition, HRV will be evaluated in ambulatory setting, at 1 month and at 6 months after the index event. Obtained interbeat interval data will be further analysed using a dedicated software in order to derive specified HRV parameters. | Procedure or surgery | – |
| Percutaneous coronary interventionAlso: PCICoronary angiography and PCI will be performed using femoral or radial approach after local anesthetic infiltration with Lidocaine and arterial sheath placement. Following the culprit lesion detection and guidewire placement, thromboaspiration and glycoprotein IIb/IIIa inhibitors will be left to the operator decision. Also, the choice of coronary stenting technique and stent sizing will be performed according to the operator experience. Antiplatelet and anticoagulant drugs will be administered in concordance with latest European guidelines. | Procedure or surgery | – |
Primary outcome
Composite of all-cause mortality and major adverse cardiovascular events (MACE)
Time frame: in-hospital, 1 month and 1 year
MACE will be defined as cardiac mortality, fatal and non-fatal myocardial infarction, unplanned target vessel revascularization and stroke)
6 secondary outcomes
All-cause mortality
Time frame: in-hospital, 1 month and 1 year
Cardiac mortality
Time frame: in-hospital, 1 month and 1 year
Fatal and non-fatal myocardial infarction
Time frame: in-hospital, 1 month and 1 year
Target vessel revascularization
Time frame: in-hospital, 1 month and 1 year
Target lesion revascularization
Time frame: in-hospital, 1 month and 1 year
Stroke
Time frame: in-hospital, 1 month and 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2021.
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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.
Adrian Covic, Professor study chair
Gr T Popa University of Medicine and Pharmacy Iasi ROMANIA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction and Autonomic Dysfunction, 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 3 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: status not confirmed, as of the sponsor's last update on 5 Nov 2021. 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 Alexandru Burlacu, MD, PhD (+40744488580, alexandru.burlacu@umfiasi.ro), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of all-cause mortality and major adverse cardiovascular events (MACE) (time frame: in-hospital, 1 month and 1 year). 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 5 Nov 2021.