Fragmented QRSNCT01136837
The Prognostic Significance of a Fragmented QRS Complex After Primary Percutaneous Coronary Intervention
An observational study of Fragmented QRS and Primary PCI, run by Bursa Postgraduate Hospital at 1 site in Turkey (Türkiye).
Trial summary
To investigate the prognostic significance of a fragmented QRS (fQRS) complex in a patient who had undergone primary percutaneous coronary intervention (PCI). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Fragmented QRS, Primary PCI, MACE
- What is being tested?
- primary pcı
- How many people
- 85 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Nov 2008to May 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
To investigate the prognostic significance of a fragmented QRS (fQRS) complex in a patient who had undergone primary percutaneous coronary intervention (PCI).
- Conditions
- Fragmented QRS, Primary PCI, MACE
- Being tested
- primary pcı
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
primary pcıOther
| Study group | Role | What they receive |
|---|---|---|
| fragmented QRS positive | fQRS at 48 hours after Primary PCI Receives: Other: primary pcı |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2010 (estimated)
- Study startNov 2008
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fragmented QRSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa Postgraduate Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01136837
- Sponsor's protocol ID
- BYİEAH-3
- Status last verified
- Nov 2008
- First submitted
- 2 Jun 2010
- Last updated
- 4 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 21344317
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prognostic Significance of a Fragmented QRS Complex After Primary Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT01136837
- Acronym / sponsor ID
- BYİEAH-3
- Conditions
- Fragmented QRS, Primary PCI, MACE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Bursa Postgraduate HospitalUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 4 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the prognostic significance of a fragmented QRS (fQRS) complex in a patient who had undergone primary percutaneous coronary intervention (PCI).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fragmented QRS positive | – | Other: primary pcıfQRS at 48 hours after Primary PCI |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| primary pcı | Other | fragmented QRS positive |
Primary outcome
Major Adverse Cardiac Events
the presence of a fQRS at 48 hours after primary PCI is a significant parameter in predicting adverse cardiovascular events;
1 secondary outcome
Q Wave and QRS distortion for predicting major adverse cardiac events
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2010.
- Derived from this study: PubMed 21344317Ari 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fragmented QRS and Primary PCI, run by Bursa Postgraduate Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiac Events. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01136837, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2010.