Myocardial InfarctionRAPIDNCT01759043
Safety and Feasibility of Using a Single Transradial Guiding Catheter for Primary PCI
A study testing guiding catheter and diagnostic catheter in people with Myocardial Infarction, run by Beijing Luhe Hospital at 1 site in China.
Trial summary
The Rapid Trial is a randomized-controlled trial proposed to test the hypothesis that using a single guiding catheter for left and right coronary angiography and intervention in patients with ST elevation myocardial infarction (STEMI) can reduce procedure time, fluoroscopy time and Cath Lab door to balloon(C2B) time… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- guiding catheter and diagnostic catheter
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- Dec 2012to Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must be > 18 years of age.
- Patients have typical chest pain for at least 20 minutes and have ECG changes typical for STEMI (ST elevation≥2mm in two continuous precordial leads or ST elevations≥1mm in two limb leads or new left bundle branch block) or ECG changes compatible with true posterior MI.
- Symptoms ≥ 30 min and ≤12 hours
- Patient and treating interventional cardiologist agree for randomization.
- Patient provides written informed consent.
- Diagnostic and therapeutic intervention performed through trans-radial/ulnar artery approach.
- Palpable radial or ulnar artery
- Previous experience of the operator with at least 100 cases of radial artery access within the past year
Who cannot join
- Concurrent participation in other investigational study
- Current platelet count <100 x 10^9cells/L or Hgb <10 g/dL.
- Absence of radial or ulnar artery pulsation
- Active bleeding or significant increased risk of bleeding, severe hepatic insufficiency, current peptic ulceration, proliferative diabetic retinopathy.
- Uncontrolled hypertension
- Prior CABG surgery
- Fibrinolytic therapy for current MI treatment
- patient have a life expectancy of <180days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Feasibility of Using a Single Transradial Guiding Catheter for Both Left and Right Coronary Angiography and Intervention in Patients With ST-segment Myocardial Infarction(RAPID)
The Rapid Trial is a randomized-controlled trial proposed to test the hypothesis that using a single guiding catheter for left and right coronary angiography and intervention in patients with ST elevation myocardial infarction (STEMI) can reduce procedure time, fluoroscopy time and Cath Lab door to balloon(C2B) time when compared with traditional approach which first underwent coronary angiography with diagnostic catheter followed by guiding catheter selection for intervention.
Read the detailed description
- background: Coronary intervention using transradial approach is common worldwide. It is normally necessary to use one diagnostic catheter and guiding catheter in primary percutaneous coronary intervention (PCI) for ST elevation myocardial infarction (STEMI). It is unknown whether using a single guiding catheter for both nonculprit and culprit vessel angiography and intervention during transradial primary percutaneous coronary intervention (PCI) is feasible.
- objective:The aim of this study is to investigate the feasibility of using a single guiding catheter for left and right coronary angiography and intervention in patients with ST elevation myocardial infarction (STEMI).
- This was a single-center, prospective, randomized study,patients with STEMI indicated for transradial primary PCI were randomized into two groups : group I consisted of patients who underwent coronary angiography and primary PCI by using a single guiding catheter.GroupII included patients who first underwent coronary angiography with diagnostic catheter followed by guiding catheter selection for intervention.
- the primary Endpoints a.Cath Lab door to balloon time (C2B)
- the Secondary endpoints:
- Occurrence of major adverse cardiac events (MACE) during 6 months
- Cardiac death
- Target vessel related myocardial infarction
- Ischemia driven Target Vessel Revascularization (TVR)
- Ischemia driven Target Lesion Revascularization (TLR)
- Definite / probable stent thrombosis by ARC definition
- Number of catheters and wires used
- Vascular access complications (hematoma, aneurysm,pseudo-aneurysm, arteriovenous fistula formation, dissection, limb ischemia, bleeding)
- door to balloon time
- contrast consumption
- procedure time
- fluoroscopy time
- Conditions
- Myocardial Infarction
- Being tested
- guiding catheter, diagnostic catheter
- Keywords
- coronary artery disease, Myocardial Infarction, Radial Artery, Catheters
- Medical subject headings
- Myocardial Infarction, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
guiding catheterProcedure or surgery
using a single transradial guiding catheter for coronary angiography and intervention
diagnostic catheterProcedure or surgery
diagnostic for coronary angiography and guiding catheter selection for intervention
| Study group | Role | What they receive |
|---|---|---|
| guiding catheter | Experimental | a single transradial guiding catheter for coronary angiography and intervention in patients with STEMI Receives: Procedure: guiding catheter |
| Diagnostic catheter | Active comparator | Diagnostic catheter followed by guiding catheter selection for transradial primary PCI Receives: Procedure: diagnostic catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cath Lab door to balloon time (C2B)
Measured: 24hours
Secondary outcomes (7)
major adverse cardiac events (MACE)
Cardiac death Target vessel related myocardial infarction Ischemia driven Target Vessel Revascularization (TVR) Ischemia driven Target Lesion Revascularization (TLR) Definite / probable stent thrombosis by ARC definition
Measured: 180days
Number of catheters and wires used
Measured: 24hours
Vascular access complications (hematoma, aneurysm,pseudo-aneurysm, arteriovenous fistula formation, dissection, limb ischemia, bleeding)
Measured: 30days
door to balloon time
Measured: 24hours
contrast consumption
Measured: 24hours
procedure time
Measured: 24hours
fluoroscopy time
Measured: 24hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionApr 2014
- Study completionDec 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 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Luhe Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jincheng Guo, M.D., Study director, Beijing Luhe Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01759043
- Sponsor's protocol ID
- 2011-7071-01 CHRDS
- Other IDs
- CHRDS
- Acronym
- RAPID
- Status last verified
- Jul 2020
- First submitted
- 24 Dec 2012
- Last updated
- 15 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Guo J, Chen W, Wang G, Liu Z, Hao M, Xu M, Zhu F. Safety and Efficacy of Using a Single Transradial MAC Guiding Catheter for Coronary Angiography and Intervention in Patients with ST Elevation Myocardial Infarction. J Interv Cardiol. 2017 Feb;30(1):33-42. doi: 10.1111/joic.12346. Epub 2016 Oct 25.
PubMed 27781297
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of Using a Single Transradial Guiding Catheter for Both Left and Right Coronary Angiography and Intervention in Patients With ST-segment Myocardial Infarction(RAPID)
- ClinicalTrials.gov ID
- NCT01759043
- Acronym / sponsor ID
- RAPID / 2011-7071-01 CHRDS
- Conditions
- Myocardial Infarction
- Keywords
- coronary artery disease, Myocardial Infarction, Radial Artery, Catheters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Beijing Luhe HospitalUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 2 Jan 2013 (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.
The Rapid Trial is a randomized-controlled trial proposed to test the hypothesis that using a single guiding catheter for left and right coronary angiography and intervention in patients with ST elevation myocardial infarction (STEMI) can reduce procedure time, fluoroscopy time and Cath Lab door to balloon(C2B) time when compared with traditional approach which first underwent coronary angiography with diagnostic catheter followed by guiding catheter selection for intervention.
Detailed description
- background: Coronary intervention using transradial approach is common worldwide. It is normally necessary to use one diagnostic catheter and guiding catheter in primary percutaneous coronary intervention (PCI) for ST elevation myocardial infarction (STEMI). It is unknown whether using a single guiding catheter for both nonculprit and culprit vessel angiography and intervention during transradial primary percutaneous coronary intervention (PCI) is feasible.
- objective:The aim of this study is to investigate the feasibility of using a single guiding catheter for left and right coronary angiography and intervention in patients with ST elevation myocardial infarction (STEMI).
- This was a single-center, prospective, randomized study,patients with STEMI indicated for transradial primary PCI were randomized into two groups : group I consisted of patients who underwent coronary angiography and primary PCI by using a single guiding catheter.GroupII included patients who first underwent coronary angiography with diagnostic catheter followed by guiding catheter selection for intervention.
- the primary Endpoints a.Cath Lab door to balloon time (C2B)
- the Secondary endpoints:
- Occurrence of major adverse cardiac events (MACE) during 6 months
- Cardiac death
- Target vessel related myocardial infarction
- Ischemia driven Target Vessel Revascularization (TVR)
- Ischemia driven Target Lesion Revascularization (TLR)
- Definite / probable stent thrombosis by ARC definition
- Number of catheters and wires used
- Vascular access complications (hematoma, aneurysm,pseudo-aneurysm, arteriovenous fistula formation, dissection, limb ischemia, bleeding)
- door to balloon time
- contrast consumption
- procedure time
- fluoroscopy time
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| guiding catheter | Experimental | Procedure: guiding cathetera single transradial guiding catheter for coronary angiography and intervention in patients with STEMI |
| Diagnostic catheter | Active comparator | Procedure: diagnostic catheterDiagnostic catheter followed by guiding catheter selection for transradial primary PCI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient must be > 18 years of age.
- Patients have typical chest pain for at least 20 minutes and have ECG changes typical for STEMI (ST elevation≥2mm in two continuous precordial leads or ST elevations≥1mm in two limb leads or new left bundle branch block) or ECG changes compatible with true posterior MI.
- Symptoms ≥ 30 min and ≤12 hours
- Patient and treating interventional cardiologist agree for randomization.
- Patient provides written informed consent.
Key exclusion criteria (8 listed)
- Concurrent participation in other investigational study
- Current platelet count <100 x 10^9cells/L or Hgb <10 g/dL.
- Absence of radial or ulnar artery pulsation
- Active bleeding or significant increased risk of bleeding, severe hepatic insufficiency, current peptic ulceration, proliferative diabetic retinopathy.
- Uncontrolled hypertension
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 |
|---|---|---|
| guiding catheterusing a single transradial guiding catheter for coronary angiography and intervention | Procedure or surgery | guiding catheter |
| diagnostic catheterdiagnostic for coronary angiography and guiding catheter selection for intervention | Procedure or surgery | Diagnostic catheter |
Primary outcome
Cath Lab door to balloon time (C2B)
Time frame: 24hours
7 secondary outcomes
major adverse cardiac events (MACE)
Time frame: 180days
Number of catheters and wires used
Time frame: 24hours
Vascular access complications (hematoma, aneurysm,pseudo-aneurysm, arteriovenous fistula formation, dissection, limb ischemia, bleeding)
Time frame: 30days
door to balloon time
Time frame: 24hours
contrast consumption
Time frame: 24hours
procedure time
Time frame: 24hours
fluoroscopy time
Time frame: 24hours
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 15 Jul 2020.
- Results publication: PubMed 27781297Guo J, Chen W, Wang G, Liu Z, Hao M, Xu M, Zhu F. Safety and Efficacy of Using a Single Transradial MAC Guiding Catheter for Coronary Angiography and Intervention in Patients with ST Elevation Myocardial Infarction. J Interv Cardiol. 2017 Feb;30(1):33-42. doi: 10.1111/joic.12346. Epub 2016 Oct 25.
- Related InfoLink provided by the sponsor.
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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.
Jincheng Guo, M.D. study director
Beijing Luhe 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 guiding catheter and diagnostic catheter in people with Myocardial Infarction, run by Beijing Luhe 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 8 inclusion and 8 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 15 Jul 2020. 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?
Cath Lab door to balloon time (C2B) (time frame: 24hours). 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 NCT01759043, 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 15 Jul 2020.