NCT03854448

Brief Summary

Is to analyze the incidence and predictors of developing AF in patients with inferior infarction who undergo PCI with and without atrial and SN branches occlusion

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
109

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

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

February 24, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 26, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

February 28, 2019

Status Verified

February 1, 2019

Enrollment Period

5 months

First QC Date

February 24, 2019

Last Update Submit

February 27, 2019

Conditions

Keywords

inferior STEMI

Outcome Measures

Primary Outcomes (1)

  • incidence of atrial fibrillation in inferior STEMI patients after primary Percutaneous Coronary Intervention

    incidence of atrial fibrillation in inferior STEMI patients after primary Percutaneous Coronary Intervention

    baseline

Secondary Outcomes (1)

  • atrial branches occlusion and left atrial volume index as predictors of atrial fibrillation

    baseline

Interventions

Transthoracic Echocardiography (TTE) Left atrial ( LA) volume will be measured using standard apical two- and four-chamber views on the frame just prior to mitral valve opening and as specified by current American Society of Echocardiography guidelines (10) LA volume is indexed to body surface area. Mitral inflow velocity is obtained in the apical four-chamber view by placing a pulsed-Doppler sample volume between the tips of the mitral leaflets. Mitral annular velocity is assessed during the early phase of diastole(e=) using pulsed-wave Doppler sampling of septal mitral annular motion from the four chamber view. 24 to 48 hours Holter monitoring after 1 month after PCI

Also known as: echocardiography

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with inferior S-T elevation myocardial infarction

You may qualify if:

  • Patients with inferior STEMI who will undergo PPCI (primary percutaneous coronary intervention )

You may not qualify if:

  • A history of preexisting AF
  • Prior documentation of heart failure or reduced left ventricular ejection fraction \< 50%,
  • Severe valvular disease ( rheumatic , sclerotic ) or secondary to AMI
  • Left ventricular hypertrophy : enlargement and thickening of the walls of the ventricle
  • Patients with inferior STEMI treated with intravenous thrombolysis or conservative strategy
  • Patients with inferior STEMI who undergo primary PCI and associated with right ventricular or posterior infarction
  • History of pulmonary embolism or COPD ( chronic obstructive pulmonary disease )
  • Those with thyrotoxicosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Electrocardiography, AmbulatoryEchocardiography

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ElectrocardiographyHeart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosisMonitoring, AmbulatoryMonitoring, PhysiologicCardiac Imaging TechniquesDiagnostic ImagingUltrasonography

Study Officials

  • Yehia Taha Kishk kishk, MD

    Professor of cardiology department Assiut University

    STUDY CHAIR
  • Mohamed Ali Mohamed Tohamy tohamy, MD

    Lecturer of cardiology department Assiut University

    STUDY DIRECTOR

Central Study Contacts

ahmed atef ahmed atef atef

CONTACT

Study Design

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

Study Record Dates

First Submitted

February 24, 2019

First Posted

February 26, 2019

Study Start

March 1, 2019

Primary Completion

August 1, 2019

Study Completion

September 1, 2019

Last Updated

February 28, 2019

Record last verified: 2019-02