The Prognostic Significance of a Fragmented QRS Complex After Primary Percutaneous Coronary Intervention
This study has been completed.
Sponsor:
Bursa Postgraduate Hospital
Information provided by:
Bursa Postgraduate Hospital
ClinicalTrials.gov Identifier:
NCT01136837
First received: June 2, 2010
Last updated: June 3, 2010
Last verified: November 2008
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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 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 May 21, 2013