Study of Paced QRS Duration as a Marker of Sudden Cardiac Death

December 11, 2016 updated by: Pocono Medical Center

Assessment of Prolonged Paced QRS Duration as a Marker of Sudden Cardiac Death in Subjects With Implantable Cardioverter-defibrillators

The purpose of the study is to determine whether prolonged paced QRS duration is a marker of sudden cardiac death in subjects with implantable cardioverter-defibrillators (ICD).

Study Overview

Status

Terminated

Conditions

Detailed Description

• Methods and Procedures Subjects for this study will be enrolled from the ICD clinic at Pocono Medical Center. The ICD clinic at Pocono Medical Center is located in the cardiology office 2.4 miles from the main hospital building where patients undergo interrogation of their ICD under the direction of the principal investigator.

During a routine ICD interrogation, the patient is attached to a 3 lead surface ECG. The ICD is then checked to assess sensing and pacing parameters and impedance for leads in all cardiac chambers. Battery voltage is assessed, and any stored events which include data from any appropriate or inappropriate therapies, are examined. Appropriate therapies consist of either an ICD shock or anti-tachycardia pacing for ventricular tachyarrhythmias. Inappropriate therapies consist of either an ICD shock or anti-tachycardia pacing for an event other than ventricular tachyarrhythmias, and may be triggered by supraventricular tachyarrhythmias or electronic noise.

Once the subjects are enrolled in the study, a 12-lead ECG will be performed (instead of a 3 lead ECG) before ICD interrogation (baseline ECG). A 12 lead ECG will then be repeated while performing right ventricular pacing through the programmer at 100 beats per minute at the time of pacing threshold testing (paced ECG). QRS durations from the baseline and paced ECG will be measured electronically in leads V3-V6. The measured QRS complexes should not be preceded by an atrial or ventricular premature complex.

All subjects will then continue to be followed every three months in the ICD clinic for routine ICD interrogation as clinically indicated for the duration of the study. Data for any appropriate and inappropriate ICD therapies will be retrieved and documented in the case report form. Subjects will be considered to have suffered SCD if they meet one of the following criteria.

  • An appropriate ICD therapy (shock or anti-tachycardia pacing)
  • Death occurring within one hour of onset of cardiac symptoms
  • Death during sleep
  • Unwitnessed death in a formerly stable patient
  • Death during attempted resuscitation Data regarding mortality will be obtained from patient's family, family physician and hospital records.
  • Project Plan Based on the current patient volume in the ICD clinic, and the rate of new ICD implants, it is estimated that enrolling 250 patients will take 3 years. The study will conclude when the last enrolled patient has been followed for 2 years. The follow-up period will, therefore, be 2-5 years for patients enrolled in the study. The total study duration is therefore expected to be 5 years.
  • Data Analysis and Data Monitoring At enrollment and at each subsequent visit, the following data will be collected.
  • Demographic data: age, gender and racial and ethnic origin, height, weight and vital signs including heart rate and blood pressure
  • Co-morbid conditions: coronary artery disease, congestive heart failure, diabetes, hypertension, smoking, dyslipidemia, family history of sudden cardiac death in a first degree relative, renal failure, and others
  • Medical regimen: all medications being taken at the time of visit
  • Testing of Cardiac substrate: reports of most recent 24 hour ambulatory electrocardiography, echocardiogram, stress test, multigated acquisition scan,, cardiac catheterization and revascularization, coronary artery bypass surgery, and electrophysiological evaluation
  • Details of ICD implantation: indication for ICD implantation (primary versus secondary prevention), type of ICD implanted (single chamber, dual chamber or biventricular) as well as the manufacturer, and the position of the right ventricular lead (apical versus septal)
  • Prolonged paced QRS duration will be defined as ≥150 ms, narrow paced QRS duration will be defined as <150 ms. All baseline characteristics of patient population will be expressed as percentages. Relative risk of SCD with prolonged paced QRS duration will be determined. Kaplan-Meier analysis will be done using the end-point of appropriate ICD therapy used as a surrogate marker of SCD, and clinical SCD to generate survival curves for each subgroup .

Study Type

Observational

Enrollment (Actual)

100

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 States
    • Pennsylvania
      • East Stroudsburg, Pennsylvania, United States, 18301
        • Pocono Medical Center Physicians Associates-Cardiology

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects followed in the ICD clinic at Pocono Medical Center.

Description

Inclusion Criteria:

  • 18 years old or older
  • Male or female
  • Subjects followed in the ICD clinic at Pocono Medical Center who have undergone ICD implantation within 3 years prior to the date of enrollment, and those who undergo ICD implantation during the enrollment period, whether for primary prevention or for secondary prevention based on standard indications will be included in the study.
  • Patients with single chamber, dual chamber and biventricular devices manufactured by all three major vendors (Boston Scientific, St Jude Medical and Medtronic) will be considered.

Exclusion Criteria:

  • Life expectancy of less than one year
  • Severe reaction to the adhesive material on ECG patches

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Prolonged paced QRS group
Patients with implantable cardioverter-defibrillators with Prolonged Paced(>=150ms) QRS duration
Narrow paced QRS group
Patients with Implantable Cardioverter-Defibrillators with Narrow Paced(<150ms) QRS duration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sudden Cardiac Death
Time Frame: Subjects will be followed for the duration of the study, an expected average of 2.5 years

Subjects will be considered to have suffered SCD if they meet one of the following criteria.

  • An appropriate ICD therapy (shock or anti-tachycardia pacing)
  • Death occurring within one hour of onset of cardiac symptoms
  • Death during sleep
  • Unwitnessed death in a formerly stable patient
  • Death during attempted resuscitation
Subjects will be followed for the duration of the study, an expected average of 2.5 years

Collaborators and Investigators

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

Sponsor

Pocono Medical Center

Investigators

  • Principal Investigator: Praveer Jain, M.D., Pocono Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2013

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

September 12, 2013

First Submitted That Met QC Criteria

September 18, 2013

First Posted (Estimate)

September 23, 2013

Study Record Updates

Last Update Posted (Estimate)

December 13, 2016

Last Update Submitted That Met QC Criteria

December 11, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PMC001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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