The Usefulness of Assessing Heart Rate Variability in Patients With Acute Myocardial Infarction (HeaRt-V-AMI)

October 29, 2021 updated by: Professor Adrian Covic, Grigore T. Popa University of Medicine and Pharmacy

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Romania
      • Iaşi, Romania, 700503
        • Department of Interventional Cardiology, Institute of Cardiovascular Diseases "Prof. George IM Georgescu" Iasi
        • Contact:
        • Principal Investigator:
          • Adrian Covic, Professor
        • Principal Investigator:
          • Alexandru Burlacu, Professor
        • Principal Investigator:
          • Mariana Floria, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
in-hospital, 1 month and 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: in-hospital, 1 month and 1 year
Defined as total number of deaths from any cause
in-hospital, 1 month and 1 year
Cardiac mortality
Time Frame: in-hospital, 1 month and 1 year
Defined as number of deaths due to cardiac causes
in-hospital, 1 month and 1 year
Fatal and non-fatal myocardial infarction
Time Frame: in-hospital, 1 month and 1 year
Defined as a new myocardial infarction
in-hospital, 1 month and 1 year
Target vessel revascularization
Time Frame: in-hospital, 1 month and 1 year
Defined as unplanned PCI or coronary artery bypass graft surgery for a stenosis in another part of the vessel treated at the index PCI
in-hospital, 1 month and 1 year
Target lesion revascularization
Time Frame: in-hospital, 1 month and 1 year
Defined as repeat PCI or coronary artery bypass graft surgery of the target lesion treated at the index PCI
in-hospital, 1 month and 1 year
Stroke
Time Frame: in-hospital, 1 month and 1 year
Defined as ischemic or hemorrhagic stroke
in-hospital, 1 month and 1 year

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hospital admissions for heart failure
Time Frame: 1 year
Defined as any subsequent admission for a primary diagnosis of heart failure
1 year
Ventricular arrhythmias
Time Frame: in-hospital, 1 month and 1 year
Defined as electrocardiographic documentation of ventricular fibrillation or sustained ventricular tachycardia
in-hospital, 1 month and 1 year
Left ventricular ejection fraction (LVEF)
Time Frame: in-hospital, 1 month and 1 year
Appraised using two-dimensional transthoracic echocardiography - Simpsons method
in-hospital, 1 month and 1 year
Left ventricular diastolic dysfunction
Time Frame: in-hospital, 1 month and 1 year
Appraised using two-dimensional transthoracic echocardiography - E/A and E/e prime ratios
in-hospital, 1 month and 1 year
Composite of all-cause mortality and major adverse cardiovascular events in special subgroup of patients
Time Frame: in-hospital, 1 month and 1 year
elderly, diabetes mellitus, chronic kidney disease
in-hospital, 1 month and 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Grigore T. Popa University of Medicine and Pharmacy

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Adrian Covic, Professor, Gr T Popa University of Medicine and Pharmacy Iasi ROMANIA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 18, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 29, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 5, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HeaRt-V-AMI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Myocardial Infarction

Clinical Trials on Heart rate variability measurement

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings