The Incidence, Effect and Persistence of Fragmented-QRS, in Patients Presenting With ST-Elevation Myocardial Infarction

June 17, 2019 updated by: The Royal Wolverhampton Hospitals NHS Trust
This study will assess the incidence, effect and persistence of F-QRS (Fragmented-QRS) in STEMI (ST-elevation Myocardial Infarction) patients post-PCI (percutaneous coronary intervention). The aim is to add to the existing research field surrounding F-QRS. It is hypothesised that patients with F-QRS present on the surface ECG, following PCI, will have incurred a higher degree of damage. As a result, it is hypothesised that these patients will have reduced LV (left-ventricular) systolic function, increased incidence of regional wall motion abnormalities (RWMAs), and increased troponin levels on admission. This study will additionally look for correlations between F-QRS and culprit vessels. To our knowledge there is minimal research regarding this.

Study Overview

Status

Completed

Conditions

Detailed Description

This is a Physiological - Retrospective data collection from STEMI patients. Data from 100 STEMI patients treated with primary PCI will be extracted.

Data will be collected from presentation / initial admission, 6-week post-MI (Myocardial Infarction) clinic and 6 month post-MI clinic from the hospital system at New Cross Hospital. Data from admission includes; 12-lead ECG, echo reports and blood test results. Additionally, the 12-lead ECGs undertaken at 6-week and 6-months will be assessed for the presence of F-QRS.

Study Type

Observational

Enrollment (Actual)

64

Contacts and Locations

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

Study Locations

  • United Kingdom
    • West Midlands
      • Wolverhampton, West Midlands, United Kingdom, WV10 0QP
        • New Cross Hospital

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

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

100 STEMI patients treated with primary PCI.

Description

Inclusion Criteria:

  • Look back to data at least 12 months old in order to ensure 6-week and 6-month follow up data is available. The inclusion criteria will be patients that presented with STEMI and were treated with primary PCI.

Exclusion Criteria:

  • From the cath lab reports and clinical letters exclusions apply to patients that did not present with STEMI. In addition, patients that were not treated with primary PCI, or patients that deceased prior, during or post procedure (during hospitalization).

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

Cohorts and Interventions

Group / Cohort
STEMI patients treated with primary PCI
Database analysis only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
F-QRS measurements
Time Frame: Over 6 months
recorded from ECG
Over 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Left ventricular ejection fraction (LVEF)
Time Frame: Over 6 months
recorded from ECG
Over 6 months
T-Troponin tests
Time Frame: Over 6 months
T-Troponin tests as cardiac biomarker of myocardial damage
Over 6 months

Collaborators and Investigators

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

Sponsor

The Royal Wolverhampton Hospitals NHS Trust

Investigators

  • Principal Investigator: Joseph Kelly, The Royal Wolverhampton NHS Trust

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 (Actual)

September 1, 2017

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

May 30, 2018

Study Registration Dates

First Submitted

May 15, 2017

First Submitted That Met QC Criteria

May 15, 2017

First Posted (Actual)

May 17, 2017

Study Record Updates

Last Update Posted (Actual)

June 18, 2019

Last Update Submitted That Met QC Criteria

June 17, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017CAR93

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No IPD will be available to other researchers

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.

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