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

This study has been completed.
Sponsor:
Information provided by:
Bursa Postgraduate Hospital
ClinicalTrials.gov Identifier:
NCT01136837
First received: June 2, 2010
Last updated: June 3, 2010
Last verified: November 2008
  Purpose

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


Condition Intervention
Fragmented QRS
Primary PCI
MACE
Other: primary pcı

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Further study details as provided by Bursa Postgraduate Hospital:

Primary Outcome Measures:
  • Major Adverse Cardiac Events [ Designated as safety issue: No ]
    the presence of a fQRS at 48 hours after primary PCI is a significant parameter in predicting adverse cardiovascular events;


Secondary Outcome Measures:
  • Q Wave and QRS distortion for predicting major adverse cardiac events [ Designated as safety issue: No ]
    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


Enrollment: 85
Study Start Date: November 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
fragmented QRS positive
fQRS at 48 hours after Primary PCI
Other: primary pcı

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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.

Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01136837

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

Additional Information:
No publications provided by Bursa Postgraduate Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hasan Arı, Bursa Postgraduate Hospital
ClinicalTrials.gov Identifier: NCT01136837     History of Changes
Other Study ID Numbers: BYİEAH-3
Study First Received: June 2, 2010
Last Updated: June 3, 2010
Health Authority: Turkey: Ministry of Health

ClinicalTrials.gov processed this record on July 22, 2014