Transradial Approach, Primary PCI, ST-segment Elevation Myocardial InfarctionNCT02239757
Left vs Right Radial Approach in the Setting of Primary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction
A study testing Left radial approach and Right radial approach in people with Transradial Approach, Primary PCI, ST-segment Elevation Myocardial Infarction, run by Capital Medical University at 1 site in China.
Trial summary
Outcomes of patients with acute ST-elevation myocardial infarction (STEMI) are directly related to reperfusion time. Effect of transradial approach (left vs right) on reperfusion time has not been fully studied for SETMI patients undergoing primary percutaneous coronary intervention (PCI). Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Transradial Approach, Primary PCI, ST-segment Elevation Myocardial Infarction
- What is being tested?
- Left radial approach and Right radial approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Jan 2013to Jan 2015
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All consecutive patients with ST-segment elevation myocardial infarction within 12 hours of symptom onset for primary PCI.
Who cannot join
- Patients are excluded if they were in cardiogenic shock.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Tiantan Hospital, Capital Medical University
Beijing, 100050
About this study
Outcomes of patients with acute ST-elevation myocardial infarction (STEMI) are directly related to reperfusion time. Effect of transradial approach (left vs right) on reperfusion time has not been fully studied for SETMI patients undergoing primary percutaneous coronary intervention (PCI). The aim of this study was to randomly investigate the efficacy and safety of left radial approach for primary PCI in STEMI patients compared with right radial approach.
Read the detailed description
The investigators will enroll consecutively for 3 years all STEMI patients undergoing primary PCI.
Patients will be included within 12 hours of symptom onset for primary PCI. Patients will be excluded if they are in cardiogenic shock.
- Being tested
- Left radial approach, Right radial approach
- Keywords
- Transradial Approach, Primary PCI, ST-segment elevation myocardial infarction
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left radial approachProcedure or surgery
Primary PCI performed through left radial approach.
Right radial approachProcedure or surgery
Primary PCI performed through right radial approach.
| Study group | Role | What they receive |
|---|---|---|
| Right radial approach | Experimental | Primary PCI performed through right radial approach. Receives: Procedure: Left radial approach |
| Left radial approach | Experimental | Primary PCI performed through left radial approach. Receives: Procedure: Right radial approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Needle to balloon time
Measured: 1 day
Secondary outcomes (3)
Radiation dose
Radiation dose include cumulative air kerma (CAK) and CAK dose area product (CAK DAP)
Measured: 7 days
Fluoroscopy time
Measured: 7 days
Contrast volume
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2014 (estimated)
- Study startJan 2013
- Primary completionJan 2015
- Study completionJan 2015
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 Transradial Approach, Primary PCI, ST-segment Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Buxing Chen, Capital Medical University
- Investigators
- Buxing Chen, MD, Ph.D, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02239757
- Sponsor's protocol ID
- LERRASMI
- Other IDs
- Lerrasmi
- Status last verified
- Sep 2014
- First submitted
- 11 Sep 2014
- Last updated
- 3 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hu H, Fu Q, Chen W, Wang D, Hua X, Chen B. A prospective randomized comparison of left and right radial approach for percutaneous coronary angiography in Asian populations. Clin Interv Aging. 2014 Jun 20;9:963-8. doi: 10.2147/CIA.S64235. eCollection 2014.
PubMed 25018624
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left vs Right Radial Approach in the Setting of Primary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT02239757
- Acronym / sponsor ID
- LERRASMI
- Keywords
- Transradial Approach, Primary PCI, ST-segment elevation myocardial infarction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 15 Sep 2014 (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.
Outcomes of patients with acute ST-elevation myocardial infarction (STEMI) are directly related to reperfusion time. Effect of transradial approach (left vs right) on reperfusion time has not been fully studied for SETMI patients undergoing primary percutaneous coronary intervention (PCI). The aim of this study was to randomly investigate the efficacy and safety of left radial approach for primary PCI in STEMI patients compared with right radial approach.
Detailed description
The investigators will enroll consecutively for 3 years all STEMI patients undergoing primary PCI.
Patients will be included within 12 hours of symptom onset for primary PCI. Patients will be excluded if they are in cardiogenic shock.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Right radial approach | Experimental | Procedure: Left radial approachPrimary PCI performed through right radial approach. |
| Left radial approach | Experimental | Procedure: Right radial approachPrimary PCI performed through left radial approach. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All consecutive patients with ST-segment elevation myocardial infarction within 12 hours of symptom onset for primary PCI.
Key exclusion criteria (1 listed)
- Patients are excluded if they were in cardiogenic shock.
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 |
|---|---|---|
| Left radial approachPrimary PCI performed through left radial approach. | Procedure or surgery | Right radial approach |
| Right radial approachPrimary PCI performed through right radial approach. | Procedure or surgery | Left radial approach |
Primary outcome
Needle to balloon time
Time frame: 1 day
3 secondary outcomes
Radiation dose
Time frame: 7 days
Fluoroscopy time
Time frame: 7 days
Contrast volume
Time frame: 7 days
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 3 Aug 2015.
- Background: PubMed 25018624Hu H, Fu Q, Chen W, Wang D, Hua X, Chen B. A prospective randomized comparison of left and right radial approach for percutaneous coronary angiography in Asian populations. Clin Interv Aging. 2014 Jun 20;9:963-8. doi: 10.2147/CIA.S64235. eCollection 2014.
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.
Buxing Chen, MD, Ph.D principal investigator
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Left radial approach and Right radial approach in people with Transradial Approach, Primary PCI, ST-segment Elevation Myocardial Infarction, run by Capital Medical University at 1 site in China.
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 3 Aug 2015. 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 China. 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?
Needle to balloon time (time frame: 1 day). 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 NCT02239757, 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 3 Aug 2015.