Acute ST-segment Elevation Myocardial InfarctionRESERVENCT04861389
Distal Transradial Access for Primary Percutaneous Coronary Intervention in STEMI Patients
A study testing Arterial access in people with Acute ST-segment Elevation Myocardial Infarction and Radial Artery Occlusion, run by Shenzhen People's Hospital at 1 site in China.
Trial summary
The transradial access (TRA) is currently the preferred approach for percutaneous coronary intervention (PCI). However, in patients with ACUTE ST-segment elevation myocardial infarction (STEMI) after emergency PCI, the high incidence of THE radial artery RAO limits the future choice of the radial artery for… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute ST-segment Elevation Myocardial Infarction, Radial Artery Occlusion, Distal Radial Artery Approach
- What is being tested?
- Arterial access
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 414 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Jan 2022
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of STEMI
- To undergo emergency PCI treatment
- Palpable pulsation of the radial artery and distal radial artery
Who cannot join
- Arteriovenous fistula of radial artery and cephalic vein has been performed with regular hemodialysis
- Suspicious left main block of electrocardiogram
- Had used the radial artery percutaneous interventional treatment before
- Cardiogenic shock
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shenzhen People's Hospital
Shenzhen, Guangdong, 518020
Xin Sun, MD, +86-755-22943205, sunxinflying@163.com
About this study
Official title: The Comparison of Distal Transradial Access and Transradial Access for Primary Percutaneous Coronary Intervention in STEMI Patients（RESERVE Trial） A Single-center, Open, Prospective, Randomized Controlled Trial
The transradial access (TRA) is currently the preferred approach for percutaneous coronary intervention (PCI). However, in patients with ACUTE ST-segment elevation myocardial infarction (STEMI) after emergency PCI, the high incidence of THE radial artery RAO limits the future choice of the radial artery for percutaneous intervention. The literature reported that distal transradial access (dTRA) significantly reduced RAO after elective PCI, but the application of dTRA in emergency PCI in STEMI has not been reported. We have completed 126 cases of dTRA undergoing emergency PCI after STEMI, which has been preliminarily confirmed to be safe and effective. A single-center, open, prospective, randomized controlled study is planned to compare the use of dTRA and TRA in emergency PCI in STEMI patients. The primary endpoint was the INCIDENCE of RAO within 24 hours after surgery. This clinical study verified that dTRA compared with TRA could reduce the RAO incidence of STEMI patients after emergency PCI. The project will explore a new artery approach to reduce RAO, and provide a basis for the selection of artery approach in STEMI emergency PCI patients.
- Conditions
- Acute ST-segment Elevation Myocardial Infarction, Radial Artery Occlusion, Distal Radial Artery Approach
- Being tested
- Arterial access
- Medical subject headings
- ST Elevation Myocardial Infarction, Arterial Occlusive Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arterial accessProcedure or surgery
Arterial access for primary percutaneous coronary intervention in STEMI patients
| Study group | Role | What they receive |
|---|---|---|
| Distal transradial access (dTRA) | Experimental | Distal transradial access for primary percutaneous coronary intervention in STEMI patients Receives: Procedure: Arterial access |
| Transradial access (TRA) | Active comparator | Transradial access for primary percutaneous coronary intervention in STEMI patients Receives: Procedure: Arterial access |
What is being measured
The primary outcome is the main question the study is designed to answer.
The RAO incidence during hospitalization
The incidence of radial artery occlusion during hospitalization
Measured: 7 days
Secondary outcomes (5)
Puncture time
Puncture time
Measured: During the intervention
Compression time
Compression time
Measured: 4-24 hours
Puncture success rate
Puncture success rate
Measured: During the intervention
Incidence of hematoma, finger numbness or pain during hospitalization
Incidence of hematoma, finger numbness or pain during hospitalization
Measured: 7days
Incidence of RAO at 1 and 6 months after surgery
Incidence of RAO at 1 and 6 months after surgery
Measured: 1 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start1 Jan 2021
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute ST-segment Elevation Myocardial InfarctionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 414 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shaohong Dong, MD, Study chair, Shenzhen People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04861389
- Sponsor's protocol ID
- RESERVE.01
- Acronym
- RESERVE
- Status last verified
- Apr 2021
- First submitted
- 29 Nov 2020
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Distal Transradial Access and Transradial Access for Primary Percutaneous Coronary Intervention in STEMI Patients（RESERVE Trial） A Single-center, Open, Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04861389
- Acronym / sponsor ID
- RESERVE / RESERVE.01
- Conditions
- Acute ST-segment Elevation Myocardial Infarction, Radial Artery Occlusion, Distal Radial Artery Approach
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 414 participants (estimated)
- Lead sponsor
- Shenzhen People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 27 Apr 2021 (actual)
- 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.
The transradial access (TRA) is currently the preferred approach for percutaneous coronary intervention (PCI). However, in patients with ACUTE ST-segment elevation myocardial infarction (STEMI) after emergency PCI, the high incidence of THE radial artery RAO limits the future choice of the radial artery for percutaneous intervention. The literature reported that distal transradial access (dTRA) significantly reduced RAO after elective PCI, but the application of dTRA in emergency PCI in STEMI has not been reported. We have completed 126 cases of dTRA undergoing emergency PCI after STEMI, which has been preliminarily confirmed to be safe and effective. A single-center, open, prospective, randomized controlled study is planned to compare the use of dTRA and TRA in emergency PCI in STEMI patients. The primary endpoint was the INCIDENCE of RAO within 24 hours after surgery. This clinical study verified that dTRA compared with TRA could reduce the RAO incidence of STEMI patients after emergency PCI. The project will explore a new artery approach to reduce RAO, and provide a basis for the selection of artery approach in STEMI emergency PCI patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Distal transradial access (dTRA) | Experimental | Procedure: Arterial accessDistal transradial access for primary percutaneous coronary intervention in STEMI patients |
| Transradial access (TRA) | Active comparator | Procedure: Arterial accessTransradial access for primary percutaneous coronary intervention in STEMI patients |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of STEMI
- To undergo emergency PCI treatment
- Palpable pulsation of the radial artery and distal radial artery
Key exclusion criteria (4 listed)
- Arteriovenous fistula of radial artery and cephalic vein has been performed with regular hemodialysis
- Suspicious left main block of electrocardiogram
- Had used the radial artery percutaneous interventional treatment before
- 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 |
|---|---|---|
| Arterial accessArterial access for primary percutaneous coronary intervention in STEMI patients | Procedure or surgery | Distal transradial access (dTRA), Transradial access (TRA) |
Primary outcome
The RAO incidence during hospitalization
Time frame: 7 days
The incidence of radial artery occlusion during hospitalization
5 secondary outcomes
Puncture time
Time frame: During the intervention
Compression time
Time frame: 4-24 hours
Puncture success rate
Time frame: During the intervention
Incidence of hematoma, finger numbness or pain during hospitalization
Time frame: 7days
Incidence of RAO at 1 and 6 months after surgery
Time frame: 1 and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Individual participant dataSharing planned: No
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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.
Shaohong Dong, MD study chair
Shenzhen People's 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 Arterial access in people with Acute ST-segment Elevation Myocardial Infarction and Radial Artery Occlusion, run by Shenzhen People's Hospital 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 3 inclusion and 4 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 27 Apr 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xin Sun, MD (+86-755-22942705, sunxinflying@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The RAO incidence during hospitalization (time frame: 7 days). 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 27 Apr 2021.