ST Elevation Myocardial InfarctionSTEMI-RADIALNCT01136187
Trial Comparing Radial and Femoral Approach in Primary Percutaneous Coronary Intervention (PCI)
A study testing Access site in primary PCI in people with ST Elevation Myocardial Infarction, run by Charles University, Czech Republic at 4 sites in Czechia.
Trial summary
Percutaneous coronary interventions (PCIs) from the femoral approach have more bleeding complications related to access site in comparison to the radial approach in patients with acute coronary syndrome (ACS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST Elevation Myocardial Infarction
- What is being tested?
- Access site in primary PCI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 707 participants
- Where
- 4 sitesCzechia
- Study dates
- Oct 2009to Oct 2012
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18 years
- Admission for STEMI less than 12 hours after onset of symptoms
- Patients have typical chest pain for at least 20 minutes and have ECG changes typical for STEMI (ST elevation ≥ 2 mm in two continuous precordial leads or ST elevations ≥ 1 mm in two limb leads or new left bundle branch block) or ECG changes compatible with true posterior MI.
- Patients are planned to be treated with primary PCI
- Ability to sign written informed consent
Who cannot join
- Killip IV class or unconsciousness
- Patient disagreement
- Prior aortobifemoral bypass
- Absence of both radial or femoral artery pulsation
- Participation in another clinical trial randomizing ACS patients using antithrombotic drug.
- Negative Allen's test or Barbeau test type D
- Treatment with oral anticoagulants
Trial locations and contacts
4 sites in 1 country.
Czechia4 sites
University Hospital Hradec Kralove
Hradec Králové, 50005
Regional Hospital Liberec
Liberec, 46063
University Hospital Pilsen
Pilsen, 30460
Na Homolce Hospital
Prague, 15030
About this study
Official title: ST Elevation Myocardial Infarction Treated by RADIAL or Femoral Approach - Randomized Multicenter Study Comparing Radial Versus Femoral Approach in Primary PCI. The STEMI-RADIAL Trial.
Percutaneous coronary interventions (PCIs) from the femoral approach have more bleeding complications related to access site in comparison to the radial approach in patients with acute coronary syndrome (ACS). Major bleeding and access site complications have an important role in results of PCI for ACS and lead to higher morbidity and mortality. Primary PCIs in ST elevation myocardial infarction (STEMI) are associated with more aggressive antithrombotic treatment than in elective or semi-urgent interventions. Currently, both radial and femoral approaches are routinely used for primary PCI in STEMI. However, only non-randomized studies and registries or small randomized single center studies comparing both approaches in primary PCI have been published until now. The aim of STEMI-RADIAL trial is to evaluate potential reduction of bleeding complications in the radial approach primary PCI compared to femoral approach in randomized, multicenter study.
- Conditions
- ST Elevation Myocardial Infarction
- Being tested
- Access site in primary PCI
- Keywords
- Myocardial infarction, Primary percutaneous coronary intervention, Radial, Bleeding
- Medical subject headings
- ST Elevation Myocardial Infarction, Myocardial Infarction, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Access site in primary PCIProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Radial approach | Experimental | Primary percutaneous coronary intervention from the radial approach Receives: Procedure: Access site in primary PCI |
| Femoral approach | Active comparator | Primary percutaneous coronary intervention from the femoral approach Receives: Procedure: Access site in primary PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of bleeding or entry site complications
Measured: 30 days
Secondary outcomes (7)
Occurence of major adverse cardiovascular events
Primary access site failure - conversion to another access
Angiographical procedural success
Contrast media consumption
Procedural and fluoroscopic times
Duration of hospital / ICU stay
TVR/TLR + any new hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2010 (estimated)
- Study startOct 2009
- Primary completionApr 2012
- Study completionOct 2012
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 ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 707 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Pilsen, Regional Hospital Liberec, University Hospital Hradec Kralove, Na Homolce Hospital
- Responsible party
- Principal investigator, Ivo Bernat, Charles University, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01136187
- Sponsor's protocol ID
- STEMI-RADIAL 16-9-2009
- Acronym
- STEMI-RADIAL
- Status last verified
- Dec 2012
- First submitted
- 2 Jun 2010
- Last updated
- 21 Dec 2012
- Results posted
- No
Publications
Bernat I, Horak D, Stasek J, Mates M, Pesek J, Ostadal P, Hrabos V, Dusek J, Koza J, Sembera Z, Brtko M, Aschermann O, Smid M, Polansky P, Al Mawiri A, Vojacek J, Bis J, Costerousse O, Bertrand OF, Rokyta R. ST-segment elevation myocardial infarction treated by radial or femoral approach in a multicenter randomized clinical trial: the STEMI-RADIAL trial. J Am Coll Cardiol. 2014 Mar 18;63(10):964-72. doi: 10.1016/j.jacc.2013.08.1651. Epub 2013 Nov 21.
PubMed 24211309
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ST Elevation Myocardial Infarction Treated by RADIAL or Femoral Approach - Randomized Multicenter Study Comparing Radial Versus Femoral Approach in Primary PCI. The STEMI-RADIAL Trial.
- ClinicalTrials.gov ID
- NCT01136187
- Acronym / sponsor ID
- STEMI-RADIAL / STEMI-RADIAL 16-9-2009
- Conditions
- ST Elevation Myocardial Infarction
- Keywords
- Myocardial infarction, Primary percutaneous coronary intervention, Radial, Bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 707 participants (actual)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Collaborators
- University Hospital Pilsen, Regional Hospital Liberec, University Hospital Hradec Kralove, Na Homolce Hospital
- Study start
- Oct 2009
- Primary completion
- Apr 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 3 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.
Percutaneous coronary interventions (PCIs) from the femoral approach have more bleeding complications related to access site in comparison to the radial approach in patients with acute coronary syndrome (ACS). Major bleeding and access site complications have an important role in results of PCI for ACS and lead to higher morbidity and mortality. Primary PCIs in ST elevation myocardial infarction (STEMI) are associated with more aggressive antithrombotic treatment than in elective or semi-urgent interventions. Currently, both radial and femoral approaches are routinely used for primary PCI in STEMI. However, only non-randomized studies and registries or small randomized single center studies comparing both approaches in primary PCI have been published until now. The aim of STEMI-RADIAL trial is to evaluate potential reduction of bleeding complications in the radial approach primary PCI compared to femoral approach in randomized, multicenter study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radial approach | Experimental | Procedure: Access site in primary PCIPrimary percutaneous coronary intervention from the radial approach |
| Femoral approach | Active comparator | Procedure: Access site in primary PCIPrimary percutaneous coronary intervention from the femoral approach |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age over 18 years
- Admission for STEMI less than 12 hours after onset of symptoms
- Ability to sign written informed consent
Key exclusion criteria (7 listed)
- Killip IV class or unconsciousness
- Patient disagreement
- Prior aortobifemoral bypass
- Absence of both radial or femoral artery pulsation
- Participation in another clinical trial randomizing ACS patients using antithrombotic drug.
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 |
|---|---|---|
| Access site in primary PCI | Procedure or surgery | Femoral approach, Radial approach |
Primary outcome
Occurrence of bleeding or entry site complications
Time frame: 30 days
7 secondary outcomes
Occurence of major adverse cardiovascular events
Primary access site failure - conversion to another access
Angiographical procedural success
Contrast media consumption
Procedural and fluoroscopic times
Duration of hospital / ICU stay
TVR/TLR + any new hospitalization
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 21 Dec 2012.
- Derived from this study: PubMed 24211309Bernat I, Horak D, Stasek J, Mates M, Pesek J, Ostadal P, Hrabos V, Dusek J, Koza J, Sembera Z, Brtko M, Aschermann O, Smid M, Polansky P, Al Mawiri A, Vojacek J, Bis J, Costerousse O, Bertrand OF, Rokyta R. ST-segment elevation myocardial infarction treated by radial or femoral approach in a multicenter randomized clinical trial: the STEMI-RADIAL trial. J Am Coll Cardiol. 2014 Mar 18;63(10):964-72. doi: 10.1016/j.jacc.2013.08.1651. Epub 2013 Nov 21.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Access site in primary PCI in people with ST Elevation Myocardial Infarction, run by Charles University, Czech Republic at 4 sites in Czechia.
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 5 inclusion and 7 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 21 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Czechia. 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?
Occurrence of bleeding or entry site complications (time frame: 30 days). 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 NCT01136187, 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 21 Dec 2012.