NCT03156699

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

May 15, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 17, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2018

Completed
Last Updated

June 18, 2019

Status Verified

June 1, 2019

Enrollment Period

8 months

First QC Date

May 15, 2017

Last Update Submit

June 17, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • F-QRS measurements

    recorded from ECG

    Over 6 months

Secondary Outcomes (2)

  • Left ventricular ejection fraction (LVEF)

    Over 6 months

  • T-Troponin tests

    Over 6 months

Study Arms (1)

STEMI patients treated with primary PCI

Database analysis only

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

100 STEMI patients treated with primary PCI.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New Cross Hospital

Wolverhampton, West Midlands, WV10 0QP, United Kingdom

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Joseph Kelly

    The Royal Wolverhampton NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2017

First Posted

May 17, 2017

Study Start

September 1, 2017

Primary Completion

May 1, 2018

Study Completion

May 30, 2018

Last Updated

June 18, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

No IPD will be available to other researchers

Locations