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The Usefulness of Assessing Heart Rate Variability in Patients With Acute Myocardial Infarction

NCT05098977 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2021-11-05

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Heart rate variability measurement

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.

PROCEDURE

Percutaneous coronary intervention

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.

Sponsors & Collaborators

  • Grigore T. Popa University of Medicine and Pharmacy

    lead OTHER

Principal Investigators

  • Adrian Covic, Professor · Gr T Popa University of Medicine and Pharmacy Iasi ROMANIA

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-30
Primary Completion
2023-10-31
Completion
2024-10-31

Countries

  • Romania

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05098977 on ClinicalTrials.gov