Sudden Cardiac DeathNCT01948206
Study of Paced QRS Duration as a Marker of Sudden Cardiac Death
An observational study of Sudden Cardiac Death, run by Pocono Medical Center at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sudden Cardiac Death
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Oct 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects followed in the ICD clinic at Pocono Medical Center.
Who may be able to join
- 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.
Who cannot join
- Life expectancy of less than one year
- Severe reaction to the adhesive material on ECG patches
Trial locations and contacts
1 site in 1 country.
United States1 site
Pocono Medical Center Physicians Associates-Cardiology
East Stroudsburg, Pennsylvania, 18301
About this study
Official title: 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).
Read the 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 .
- Conditions
- Sudden Cardiac Death
- Keywords
- Sudden Cardiac Death, Implantable Cardioverter-Defibrillator, Cardiomyopathy, Prolonged Paced QRS Duration
- Medical subject headings
- Death, Sudden, Cardiac, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Sudden Cardiac Death
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
Measured: Subjects will be followed for the duration of the study, an expected average of 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2013 (estimated)
- Study startOct 2013
- Primary completionOct 2016
- Study completionOct 2016
Why it stopped: Ran out of funds
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Sudden Cardiac DeathStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pocono Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Praveer Jain, M.D., Principal investigator, Pocono Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01948206
- Sponsor's protocol ID
- PMC001
- Status last verified
- Dec 2016
- First submitted
- 12 Sep 2013
- Last updated
- 13 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Roger VL, Go AS, Lloyd-Jones DM, Benjamin EJ, Berry JD, Borden WB, Bravata DM, Dai S, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli A, Matchar DB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Soliman EZ, Sorlie PD, Sotoodehnia N, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Executive summary: heart disease and stroke statistics--2012 update: a report from the American Heart Association. Circulation. 2012 Jan 3;125(1):188-97. doi: 10.1161/CIR.0b013e3182456d46. No abstract available.
PubMed 22215894Greve AM, Gerdts E, Boman K, Gohlke-Baerwolf C, Rossebo AB, Devereux RB, Kober L, Ray S, Willenheimer R, Wachtell K. Impact of QRS duration and morphology on the risk of sudden cardiac death in asymptomatic patients with aortic stenosis: the SEAS (Simvastatin and Ezetimibe in Aortic Stenosis) Study. J Am Coll Cardiol. 2012 Mar 27;59(13):1142-9. doi: 10.1016/j.jacc.2011.12.020.
PubMed 22440214Koyak Z, Harris L, de Groot JR, Silversides CK, Oechslin EN, Bouma BJ, Budts W, Zwinderman AH, Van Gelder IC, Mulder BJ. Sudden cardiac death in adult congenital heart disease. Circulation. 2012 Oct 16;126(16):1944-54. doi: 10.1161/CIRCULATIONAHA.112.104786. Epub 2012 Sep 18.
PubMed 22991410Varma N. Left ventricular conduction delays induced by right ventricular apical pacing: effect of left ventricular dysfunction and bundle branch block. J Cardiovasc Electrophysiol. 2008 Feb;19(2):114-22. doi: 10.1111/j.1540-8167.2007.00995.x. Epub 2007 Oct 24.
PubMed 17971145Sweeney MO, Hellkamp AS. Heart failure during cardiac pacing. Circulation. 2006 May 2;113(17):2082-8. doi: 10.1161/CIRCULATIONAHA.105.608356. Epub 2006 Apr 24.
PubMed 16636167Hsing JM, Selzman KA, Leclercq C, Pires LA, McLaughlin MG, McRae SE, Peterson BJ, Zimetbaum PJ. Paced left ventricular QRS width and ECG parameters predict outcomes after cardiac resynchronization therapy: PROSPECT-ECG substudy. Circ Arrhythm Electrophysiol. 2011 Dec;4(6):851-7. doi: 10.1161/CIRCEP.111.962605. Epub 2011 Sep 28.
PubMed 21956038Pap R, Furge P, Bencsik G, Makai A, Saghy L, Forster T. Native QRS complex duration predicts paced QRS width in patients with normal left ventricular function and right ventricular pacing for atrioventricular block. J Electrocardiol. 2007 Oct;40(4):360-4. doi: 10.1016/j.jelectrocard.2006.10.060. Epub 2007 Jan 24.
PubMed 17254598Tracy CM, Epstein AE, Darbar D, Dimarco JP, Dunbar SB, Estes NA 3rd, Ferguson TB Jr, Hammill SC, Karasik PE, Link MS, Marine JE, Schoenfeld MH, Shanker AJ, Silka MJ, Stevenson LW, Stevenson WG, Varosy PD. 2012 ACCF/AHA/HRS focused update of the 2008 guidelines for device-based therapy of cardiac rhythm abnormalities: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2012 Oct 2;60(14):1297-313. doi: 10.1016/j.jacc.2012.07.009. Epub 2012 Sep 10. No abstract available.
PubMed 22975230Kurl S, Makikallio TH, Rautaharju P, Kiviniemi V, Laukkanen JA. Duration of QRS complex in resting electrocardiogram is a predictor of sudden cardiac death in men. Circulation. 2012 May 29;125(21):2588-94. doi: 10.1161/CIRCULATIONAHA.111.025577. Epub 2012 May 21.
PubMed 22615341Teodorescu C, Reinier K, Uy-Evanado A, Navarro J, Mariani R, Gunson K, Jui J, Chugh SS. Prolonged QRS duration on the resting ECG is associated with sudden death risk in coronary disease, independent of prolonged ventricular repolarization. Heart Rhythm. 2011 Oct;8(10):1562-7. doi: 10.1016/j.hrthm.2011.06.011. Epub 2011 Jun 12.
PubMed 21699869Bode-Schnurbus L, Bocker D, Block M, Gradaus R, Heinecke A, Breithardt G, Borggrefe M. QRS duration: a simple marker for predicting cardiac mortality in ICD patients with heart failure. Heart. 2003 Oct;89(10):1157-62. doi: 10.1136/heart.89.10.1157.
PubMed 12975406Morin DP, Oikarinen L, Viitasalo M, Toivonen L, Nieminen MS, Kjeldsen SE, Dahlof B, John M, Devereux RB, Okin PM. QRS duration predicts sudden cardiac death in hypertensive patients undergoing intensive medical therapy: the LIFE study. Eur Heart J. 2009 Dec;30(23):2908-14. doi: 10.1093/eurheartj/ehp321. Epub 2009 Aug 17.
PubMed 19687165Hayes JJ, Sharma AD, Love JC, Herre JM, Leonen AO, Kudenchuk PJ; DAVID Investigators. Abnormal conduction increases risk of adverse outcomes from right ventricular pacing. J Am Coll Cardiol. 2006 Oct 17;48(8):1628-33. doi: 10.1016/j.jacc.2006.05.071. Epub 2006 Sep 26.
PubMed 17045899Buxton AE, Sweeney MO, Wathen MS, Josephson ME, Otterness MF, Hogan-Miller E, Stark AJ, Degroot PJ; PainFREE Rx II Investigators. QRS duration does not predict occurrence of ventricular tachyarrhythmias in patients with implanted cardioverter-defibrillators. J Am Coll Cardiol. 2005 Jul 19;46(2):310-6. doi: 10.1016/j.jacc.2005.03.060.
PubMed 16022960Bauer A, Watanabe MA, Barthel P, Schneider R, Ulm K, Schmidt G. QRS duration and late mortality in unselected post-infarction patients of the revascularization era. Eur Heart J. 2006 Feb;27(4):427-33. doi: 10.1093/eurheartj/ehi683. Epub 2005 Dec 7.
PubMed 16338936
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Prolonged Paced QRS Duration as a Marker of Sudden Cardiac Death in Subjects With Implantable Cardioverter-defibrillators
- ClinicalTrials.gov ID
- NCT01948206
- Acronym / sponsor ID
- PMC001
- Conditions
- Sudden Cardiac Death
- Keywords
- Sudden Cardiac Death, Implantable Cardioverter-Defibrillator, Cardiomyopathy, Prolonged Paced QRS Duration
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Ran out of funds
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Pocono Medical CenterUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 23 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects followed in the ICD clinic at Pocono Medical Center.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Life expectancy of less than one year
- Severe reaction to the adhesive material on ECG patches
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study was stopped early (reason given: Ran out of funds). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2016.
- Background: PubMed 22215894Roger VL, Go AS, Lloyd-Jones DM, Benjamin EJ, Berry JD, Borden WB, Bravata DM, Dai S, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli A, Matchar DB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Soliman EZ, Sorlie PD, Sotoodehnia N, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Executive summary: heart disease and stroke statistics--2012 update: a report from the American Heart Association. Circulation. 2012 Jan 3;125(1):188-97. doi: 10.1161/CIR.0b013e3182456d46. No abstract available.
- Background: PubMed 22440214Greve AM, Gerdts E, Boman K, Gohlke-Baerwolf C, Rossebo AB, Devereux RB, Kober L, Ray S, Willenheimer R, Wachtell K. Impact of QRS duration and morphology on the risk of sudden cardiac death in asymptomatic patients with aortic stenosis: the SEAS (Simvastatin and Ezetimibe in Aortic Stenosis) Study. J Am Coll Cardiol. 2012 Mar 27;59(13):1142-9. doi: 10.1016/j.jacc.2011.12.020.
- Background: PubMed 22991410Koyak Z, Harris L, de Groot JR, Silversides CK, Oechslin EN, Bouma BJ, Budts W, Zwinderman AH, Van Gelder IC, Mulder BJ. Sudden cardiac death in adult congenital heart disease. Circulation. 2012 Oct 16;126(16):1944-54. doi: 10.1161/CIRCULATIONAHA.112.104786. Epub 2012 Sep 18.
- Background: PubMed 17971145Varma N. Left ventricular conduction delays induced by right ventricular apical pacing: effect of left ventricular dysfunction and bundle branch block. J Cardiovasc Electrophysiol. 2008 Feb;19(2):114-22. doi: 10.1111/j.1540-8167.2007.00995.x. Epub 2007 Oct 24.
- Background: PubMed 16636167Sweeney MO, Hellkamp AS. Heart failure during cardiac pacing. Circulation. 2006 May 2;113(17):2082-8. doi: 10.1161/CIRCULATIONAHA.105.608356. Epub 2006 Apr 24.
- Background: PubMed 21956038Hsing JM, Selzman KA, Leclercq C, Pires LA, McLaughlin MG, McRae SE, Peterson BJ, Zimetbaum PJ. Paced left ventricular QRS width and ECG parameters predict outcomes after cardiac resynchronization therapy: PROSPECT-ECG substudy. Circ Arrhythm Electrophysiol. 2011 Dec;4(6):851-7. doi: 10.1161/CIRCEP.111.962605. Epub 2011 Sep 28.
- Background: PubMed 17254598Pap R, Furge P, Bencsik G, Makai A, Saghy L, Forster T. Native QRS complex duration predicts paced QRS width in patients with normal left ventricular function and right ventricular pacing for atrioventricular block. J Electrocardiol. 2007 Oct;40(4):360-4. doi: 10.1016/j.jelectrocard.2006.10.060. Epub 2007 Jan 24.
- Background: PubMed 22975230Tracy CM, Epstein AE, Darbar D, Dimarco JP, Dunbar SB, Estes NA 3rd, Ferguson TB Jr, Hammill SC, Karasik PE, Link MS, Marine JE, Schoenfeld MH, Shanker AJ, Silka MJ, Stevenson LW, Stevenson WG, Varosy PD. 2012 ACCF/AHA/HRS focused update of the 2008 guidelines for device-based therapy of cardiac rhythm abnormalities: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2012 Oct 2;60(14):1297-313. doi: 10.1016/j.jacc.2012.07.009. Epub 2012 Sep 10. No abstract available.
- Results publication: PubMed 22615341Kurl S, Makikallio TH, Rautaharju P, Kiviniemi V, Laukkanen JA. Duration of QRS complex in resting electrocardiogram is a predictor of sudden cardiac death in men. Circulation. 2012 May 29;125(21):2588-94. doi: 10.1161/CIRCULATIONAHA.111.025577. Epub 2012 May 21.
- Results publication: PubMed 21699869Teodorescu C, Reinier K, Uy-Evanado A, Navarro J, Mariani R, Gunson K, Jui J, Chugh SS. Prolonged QRS duration on the resting ECG is associated with sudden death risk in coronary disease, independent of prolonged ventricular repolarization. Heart Rhythm. 2011 Oct;8(10):1562-7. doi: 10.1016/j.hrthm.2011.06.011. Epub 2011 Jun 12.
- Results publication: PubMed 12975406Bode-Schnurbus L, Bocker D, Block M, Gradaus R, Heinecke A, Breithardt G, Borggrefe M. QRS duration: a simple marker for predicting cardiac mortality in ICD patients with heart failure. Heart. 2003 Oct;89(10):1157-62. doi: 10.1136/heart.89.10.1157.
- Results publication: PubMed 19687165Morin DP, Oikarinen L, Viitasalo M, Toivonen L, Nieminen MS, Kjeldsen SE, Dahlof B, John M, Devereux RB, Okin PM. QRS duration predicts sudden cardiac death in hypertensive patients undergoing intensive medical therapy: the LIFE study. Eur Heart J. 2009 Dec;30(23):2908-14. doi: 10.1093/eurheartj/ehp321. Epub 2009 Aug 17.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Praveer Jain, M.D. principal investigator
Pocono Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sudden Cardiac Death, run by Pocono Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Ran out of funds). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sudden Cardiac Death (time frame: Subjects will be followed for the duration of the study, an expected average of 2.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01948206, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2016.