The Prognostic Significance of a Fragmented QRS Complex After Primary Percutaneous Coronary Intervention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01136837
Recruitment Status : Completed
First Posted : June 4, 2010
Last Update Posted : June 4, 2010
Information provided by:
Bursa Postgraduate Hospital

Brief Summary:
To investigate the prognostic significance of a fragmented QRS (fQRS) complex in a patient who had undergone primary percutaneous coronary intervention (PCI).

Condition or disease Intervention/treatment
Fragmented QRS Primary PCI MACE Other: primary pcı

Study Type : Observational
Actual Enrollment : 85 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : November 2008
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Group/Cohort Intervention/treatment
fragmented QRS positive
fQRS at 48 hours after Primary PCI
Other: primary pcı

Primary Outcome Measures :
  1. Major Adverse Cardiac Events
    the presence of a fQRS at 48 hours after primary PCI is a significant parameter in predicting adverse cardiovascular events;

Secondary Outcome Measures :
  1. Q Wave and QRS distortion for predicting major adverse cardiac events
    the presence of a fQRS is a more sensitive and specific parameter in predicting development of adverse cardiovascular events than Q wave and QRS distortion; and compared to Q wave, fQRS correlated more significantly with the presence of a scar

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
patients who presented to the hospital within 12 hours of the onset of chest pain who were admitted to the coronary intensive care unit (ICU) with the diagnosis of acute STEMI and who were administered primary PCI. Having acute STEMI for the first time was stipulated for inclusion in the study.

Inclusion Criteria:

  • Patients with chest pain that continued longer than 30 minutes and with ≥ 2 mm ST elevation in ECG at least in two adjacent derivations were diagnosed with an acute STEMI. In all patients, at least two-fold increases were seen in serum CK-MB levels compared to normal values.Having acute STEMI for the first time was stipulated for inclusion in the study.

Exclusion Criteria:

  • Subjects with known allergies to aspirin and clopidogrel, inadequate echocardiographic images, malignancy, a previous cerebrovascular event, renal dysfunction (creatine level > 2.5 mg/dl), a previous MI, or a history of cardiogenic shock as well as those who refused to participate in the study were excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01136837

Bursa Yüksek İhtisas Hastanesi
Bursa, Turkey, 16330
Sponsors and Collaborators
Bursa Postgraduate Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hasan Arı, Bursa Postgraduate Hospital Identifier: NCT01136837     History of Changes
Other Study ID Numbers: BYİEAH-3
First Posted: June 4, 2010    Key Record Dates
Last Update Posted: June 4, 2010
Last Verified: November 2008