NCT01136837

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 4, 2010

Completed
Last Updated

June 4, 2010

Status Verified

November 1, 2008

Enrollment Period

6 months

First QC Date

June 2, 2010

Last Update Submit

June 3, 2010

Conditions

Outcome Measures

Primary Outcomes (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 Outcomes (1)

  • Q Wave and QRS distortion for predicting major adverse cardiac events

Study Arms (1)

fragmented QRS positive

fQRS at 48 hours after Primary PCI

Other: primary pcı

Interventions

fragmented QRS positive

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa Yüksek İhtisas Hastanesi

Bursa, 16330, Turkey (Türkiye)

Location

Related Publications (1)

  • 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 Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 2, 2010

First Posted

June 4, 2010

Study Start

November 1, 2008

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

June 4, 2010

Record last verified: 2008-11

Locations