Myocardial InfarctionFLAWLESsNCT02788799
Finding LCX AMI With Posterior ECG LeadS
An observational study of Myocardial Infarction, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Along with symptoms of chest pain, the presence of ST segment elevations on ECG is the criterion usually used in practice to identify patients with acute coronary artery occlusion and is essential for the direct and acute referral of patients for primary PCI. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Standard 12-Lead ECG and Posterior ECG Leads
- How many people
- 1,200 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2017to Dec 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The intervention group will contain STEMI patients referred directly from the pre-hospital setting to PCI-center for primary PCI during study periode. In these patients, both standard 12-lead ECG and ECG with V7-V9 leads will be recorded and tele-transmitted to the PCI-center.
Who may be able to join
- All STEMI patients referred directly from the pre-hospital setting, treated with primary PCI and with available standard 12-lead ECG and ECG with V7-V9 leads.
Who cannot join
- STEMI patients treated with primary PCI and no ECG with V7-V9 leads.
Trial locations and contacts
1 site in 1 country.
Jens Kastrup, MD, Professor contact
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet
Copenhagen
Yama Fakhri, MD
About this study
Official title: Clinical Impact of Pre-hospital Posterior ECG Leads Implementation for Identifying Occlusion of Left Circumflex Coronary Artery in ST Segment Elevation Myocardial Infarction
Along with symptoms of chest pain, the presence of ST segment elevations on ECG is the criterion usually used in practice to identify patients with acute coronary artery occlusion and is essential for the direct and acute referral of patients for primary PCI. However, ECG does not always reflect changes in the posterior wall of the heart, often equivalent to the left circumflex coronary artery's (LCX) supply area, resulting in an underrepresentation of LCX as culprit artery in STEMI populations. There is a general concern that some patients with genuine acute occlusion of LCX may present without ST segment elevation and be denied reperfusion therapy, resulting in larger infarction and worse outcome.
The aim of this trial is to implement record of posterior ECG leads (V7, V8 and V9) in addition to the standard 12-lead ECG in the pre-hospital setting and to evaluate the clinical impact of this implementation: In comparison to a control cohort of STEMI patients diagnosed with a pre-hospital standard 12-lead ECG prior study start, the investigators hypothesize that introducing V7-V9 leads as a clinical routine in the pre-hospital setting will identify patients with STEMI involving LCX and with a non-diagnostic standard 12-lead ECG.
- Conditions
- Myocardial Infarction
- Being tested
- Standard 12-Lead ECG, Posterior ECG Leads
- Keywords
- ST Elevation, LCX Artery
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard 12-Lead ECGOther
Conventional record of Standard 12-lead ECG in every patient with suspect of acute coronary syndrome.
Posterior ECG LeadsOther
Also called Posterior Leads (V7, V8 and V9)
Recording posterior ECG leads (V7, V8 and V9) in addition to standard 12-lead ECG for identifying STEMI involving left cirumflex coronary artery.
| Study group | Role | What they receive |
|---|---|---|
| Control | Not described Receives: Other: Standard 12-Lead ECG | |
| Intervention | Not described Receives: Other: Standard 12-Lead ECG; Other: Posterior ECG Leads |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with LCX occlusion as culprit artery in the intervention group compared to the control group
Measured: Day one - culprit lesion treated with primary PCI
Secondary outcomes (1)
Proportion of patients in the intervention group with STEMI involving LCX artery, non-diagnostic standard 12-lead ECG and ST segment elevation >0,5 mm in ≥2 leads in posterior ECG leads (V7-V9).
Measured: Day one - culprit lesion treated with primary PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2016 (estimated)
- Study start1 Feb 2017
- Primary completion31 Aug 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Other
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Nykøbing Falster County Hospital, Region Sjælland
- Responsible party
- Principal investigator, Yama Fakhri, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Jens Kastrup, MD,Professor, Study chair, Dept of Cardiology, Rigshospitalet, Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02788799
- Sponsor's protocol ID
- FLAWLESS-16-YF
- Acronym
- FLAWLESs
- Status last verified
- Mar 2019
- First submitted
- 26 May 2016
- Last updated
- 28 Mar 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Impact of Pre-hospital Posterior ECG Leads Implementation for Identifying Occlusion of Left Circumflex Coronary Artery in ST Segment Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT02788799
- Acronym / sponsor ID
- FLAWLESs / FLAWLESS-16-YF
- Conditions
- Myocardial Infarction
- Keywords
- ST Elevation, LCX Artery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Nykøbing Falster County Hospital, Region Sjælland
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 31 Aug 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 2 Jun 2016 (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.
Along with symptoms of chest pain, the presence of ST segment elevations on ECG is the criterion usually used in practice to identify patients with acute coronary artery occlusion and is essential for the direct and acute referral of patients for primary PCI. However, ECG does not always reflect changes in the posterior wall of the heart, often equivalent to the left circumflex coronary artery's (LCX) supply area, resulting in an underrepresentation of LCX as culprit artery in STEMI populations. There is a general concern that some patients with genuine acute occlusion of LCX may present without ST segment elevation and be denied reperfusion therapy, resulting in larger infarction and worse outcome.
The aim of this trial is to implement record of posterior ECG leads (V7, V8 and V9) in addition to the standard 12-lead ECG in the pre-hospital setting and to evaluate the clinical impact of this implementation: In comparison to a control cohort of STEMI patients diagnosed with a pre-hospital standard 12-lead ECG prior study start, the investigators hypothesize that introducing V7-V9 leads as a clinical routine in the pre-hospital setting will identify patients with STEMI involving LCX and with a non-diagnostic standard 12-lead ECG.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | Other: Standard 12-Lead ECG |
| Intervention | – | Other: Standard 12-Lead ECG, Other: Posterior ECG Leads |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The intervention group will contain STEMI patients referred directly from the pre-hospital setting to PCI-center for primary PCI during study periode. In these patients, both standard 12-lead ECG and ECG with V7-V9 leads will be recorded and tele-transmitted to the PCI-center.
Key inclusion criteria (1 listed)
- All STEMI patients referred directly from the pre-hospital setting, treated with primary PCI and with available standard 12-lead ECG and ECG with V7-V9 leads.
Key exclusion criteria (1 listed)
- STEMI patients treated with primary PCI and no ECG with V7-V9 leads.
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 |
|---|---|---|
| Standard 12-Lead ECGConventional record of Standard 12-lead ECG in every patient with suspect of acute coronary syndrome. | Other | Control, Intervention |
| Posterior ECG LeadsAlso: Posterior Leads (V7, V8 and V9)Recording posterior ECG leads (V7, V8 and V9) in addition to standard 12-lead ECG for identifying STEMI involving left cirumflex coronary artery. | Other | Intervention |
Primary outcome
Proportion of patients with LCX occlusion as culprit artery in the intervention group compared to the control group
Time frame: Day one - culprit lesion treated with primary PCI
1 secondary outcome
Proportion of patients in the intervention group with STEMI involving LCX artery, non-diagnostic standard 12-lead ECG and ST segment elevation >0,5 mm in ≥2 leads in posterior ECG leads (V7-V9).
Time frame: Day one - culprit lesion treated with primary PCI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2019.
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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.
Jens Kastrup, MD, Professor contact
Jens Kastrup, MD,Professor study chair
Dept of Cardiology, Rigshospitalet, Copenhagen, Denmark
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 Myocardial Infarction, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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: status not confirmed, as of the sponsor's last update on 28 Mar 2019. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yama Fakhri, MD (+4535451196, yama.said.fakhri@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with LCX occlusion as culprit artery in the intervention group compared to the control group (time frame: Day one - culprit lesion treated with primary PCI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Mar 2019.