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

Primary PCI Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01136837
• Other study ID #: BYIEAH-3
• Status: Completed
• Phase: N/A
• First received: June 2, 2010
• Last updated: June 3, 2010
• Start date: November 2008
• Est. completion date: May 2009

Study information

• Verified date: November 2008
• Source: Bursa Postgraduate Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fragmented QRS
• MACE
• Primary PCI

Intervention

Other:
• primary pci

Locations

Country	Name	City	State
Turkey	Bursa Yüksek Ihtisas Hastanesi	Bursa

Sponsors (1)

Lead Sponsor	Collaborator
Bursa Postgraduate Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Adverse Cardiac Events	the presence of a fQRS at 48 hours after primary PCI is a significant parameter in predicting adverse cardiovascular events;		No
Secondary	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		No

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