NCT05098977

Brief 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 (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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 29, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

November 5, 2021

Status Verified

October 1, 2021

Enrollment Period

1.9 years

First QC Date

October 18, 2021

Last Update Submit

October 29, 2021

Conditions

Myocardial InfarctionAutonomic Dysfunction

Keywords

Heart rate variabilityPercutaneous coronary interventionDrug-eluting stentsRisk assessmentPrognosisMajor adverse cardiovascular eventsLeft ventricular ejection fractionSecondary prevention

Outcome Measures

Primary Outcomes (1)

  • 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)

    in-hospital, 1 month and 1 year

Secondary Outcomes (6)

  • All-cause mortality

    in-hospital, 1 month and 1 year

  • Cardiac mortality

    in-hospital, 1 month and 1 year

  • Fatal and non-fatal myocardial infarction

    in-hospital, 1 month and 1 year

  • Target vessel revascularization

    in-hospital, 1 month and 1 year

  • Target lesion revascularization

    in-hospital, 1 month and 1 year

  • +1 more secondary outcomes

Other Outcomes (5)

  • Hospital admissions for heart failure

    1 year

  • Ventricular arrhythmias

    in-hospital, 1 month and 1 year

  • Left ventricular ejection fraction (LVEF)

    in-hospital, 1 month and 1 year

  • +2 more other outcomes

Interventions

Heart rate variability measurementPROCEDURE

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

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.

Also known as: PCI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Interventional Cardiology, Institute of Cardiovascular Diseases "Prof. George IM Georgescu" Iasi

Iași, 700503, Romania

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

CK-MB, AST, LDH, cardiac-specific troponin, glycemia, glycosylated hemoglobin, lipid profile, complete blood count, hemoglobin, hematocrit, serum urea and creatinine (estimated glomerular filtration rate using CKD-EPI equation), serum potassium and sodium, sideremia, plasma ferritin, thyroid-stimulating hormone, serum thyroxine, C-reactive protein, N-terminal pro b-type natriuretic peptide.

MeSH Terms

Conditions

Myocardial InfarctionPrimary Dysautonomias

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisAutonomic Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Adrian Covic, Professor

    Gr T Popa University of Medicine and Pharmacy Iasi ROMANIA

    STUDY CHAIR

Central Study Contacts

Alexandru Burlacu, MD, PhD

CONTACT

+40744488580alexandru.burlacu@umfiasi.ro

Crischentian Brinza, MD

CONTACT

+40758431764crischentian.brinza@d.umfiasi.ro

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor coordinator

Study Record Dates

First Submitted

October 18, 2021

First Posted

October 29, 2021

Study Start

November 1, 2021

Primary Completion

October 1, 2023

Study Completion

October 1, 2024

Last Updated

November 5, 2021

Record last verified: 2021-10

Locations

RO(1)