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

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

Study Overview

• Status: Completed
• Conditions: Primary PCI; Fragmented QRS; MACE
• Intervention / Treatment: Other: primary pcı

• Study Type: Observational
• Enrollment (Actual): 85

Contacts and Locations

Study Locations

• Turkey
  • Bursa, Turkey, 16330
    • Bursa Yüksek İhtisas Hastanesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description
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

Outcome Measure	Measure Description
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

Collaborators and Investigators

• Sponsor: Bursa Postgraduate Hospital

Publications and helpful links

General Publications

• Ari H, Cetinkaya S, Ari S, Koca V, Bozat T. The prognostic significance of a fragmented QRS complex after primary percutaneous coronary intervention. Heart Vessels. 2012 Jan;27(1):20-8. doi: 10.1007/s00380-011-0121-9. Epub 2011 Feb 23.

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: June 2, 2010
• First Submitted That Met QC Criteria: June 3, 2010
• First Posted (Estimate): June 4, 2010

Study Record Updates

• Last Update Posted (Estimate): June 4, 2010
• Last Update Submitted That Met QC Criteria: June 3, 2010
• Last Verified: November 1, 2008

More Information

Terms related to this study

• Other Study ID Numbers: BYİEAH-3