Myocardial InfarctionNCT03272451
ECG-guided Immediate Primary PCI for Culprit Vessel to Reduce Door to Device Time
A study testing culprit vessel intervention and traditional approach in people with Myocardial Infarction, run by Beijing Luhe Hospital at 2 sites in China.
Trial summary
No consensus exists about which coronary artery should be firstly catheterized in primary percutaneous coronary intervention (PCI). The aim of the present study was to compare door-to-balloon time (D2B) of ECG guided immediate infarct-related artery (IRA) PCI with traditional complete coronary angiography followed by… 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?
- culprit vessel intervention and traditional approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 560 participants
- Where
- 2 sitesChina
- Study dates
- 10 Feb 2017to 31 Jul 2019
- 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 transradial artery approach
- Palpable radial artery.
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 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
2 sites in 1 country.
About this study
Official title: ECG-guided Immediate pRimAry Percutaneous Coronary Intervention for Culprit Vessel Using a Transradial Single Guiding Catheter to Reduce Door to Device Time: RAPID II Study
No consensus exists about which coronary artery should be firstly catheterized in primary percutaneous coronary intervention (PCI). The aim of the present study was to compare door-to-balloon time (D2B) of ECG guided immediate infarct-related artery (IRA) PCI with traditional complete coronary angiography followed by PCI for the treatment of ST segment elevation myocardial infarction (STEMI) patients. Primary endpoint is door to device (D2D) time. Secondary end-points are: puncture to device (P2D) time,first medical contact to device (FMC2D) time,incidence of radial artery spasm and occlusion, contrast amount, fluoroscopy time, cumulative air kerma(CAK) and dose area product(DAP).
- Conditions
- Myocardial Infarction
- Being tested
- culprit vessel intervention, traditional approach
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
culprit vessel interventionProcedure or surgery
ECG guided immediate culprit vessel intervention using a single transradial guiding catheter such as MAC or JL 3.5
traditional approachProcedure or surgery
single diagnostic catheter for complete coronary angiography and guiding catheter selection for PCI
| Study group | Role | What they receive |
|---|---|---|
| culprit vessel intervention | Experimental | culprit vessel PCI prior to contralateral angiography using a single transradial guiding catheter Receives: Procedure: culprit vessel intervention |
| traditional approach | Active comparator | complete coronary angiography followed by guiding catheter selection for culprit vessel PCI Receives: Procedure: traditional approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
door to device (D2D) time
time patient's arrival at our hospital to first device (balloon,aspiration catheter or stent) use
Measured: 24hours
Secondary outcomes (6)
puncture to device (P2D) time
time from radail artery puncture to first device(balloon,aspiration catheter or stent) use
Measured: 24hours
first medical contact to device (FMC2D) time
time from first medical contact to first device (balloon,aspiration catheter or stent) use.
Measured: 24hours
incidence of radial artery spasm
radial artery spasms were defined as follows. Severe, moderate, and mild based on radiao angiography before and after procedure
Measured: during the procedure (time from the guide catheter inserted to guide catheter removed)
incidence of radial artery occlusion
the absence of palpable radial artery pulsation confirmed by echocardiogram
Measured: inhospital (an expected average of 5 days),30day,12month
fluoroscopy time
recorded on the machine
Measured: 1 hour
cumulative air kerma(CAK) and dose area product(DAP).
recorded on the machine
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2017
- Study start10 Feb 2017
- Primary completion15 Jul 2019
- Study completion31 Jul 2019
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
- None (open label)
- Enrolment
- 560 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Luhe Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03272451
- Sponsor's protocol ID
- BeijingLH
- Status last verified
- May 2022
- First submitted
- 30 Aug 2017
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Guo J, Wang G, Li Z, Liu Z, Wang Y, Wang S, Wang Y, Wu Y, Wang H, Wang Y, Zhang L, Hua Q. Culprit vessel revascularization first with primary use of a dedicated transradial guiding catheter to reduce door to balloon time in primary percutaneous coronary intervention. Front Cardiovasc Med. 2022 Oct 28;9:1022488. doi: 10.3389/fcvm.2022.1022488. eCollection 2022.
PubMed 36386357
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ECG-guided Immediate pRimAry Percutaneous Coronary Intervention for Culprit Vessel Using a Transradial Single Guiding Catheter to Reduce Door to Device Time: RAPID II Study
- ClinicalTrials.gov ID
- NCT03272451
- Acronym / sponsor ID
- BeijingLH
- Conditions
- Myocardial Infarction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 560 participants (actual)
- Lead sponsor
- Beijing Luhe HospitalUniversity, hospital or other
- Study start
- 10 Feb 2017 (actual)
- Primary completion
- 15 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 5 Sep 2017 (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.
No consensus exists about which coronary artery should be firstly catheterized in primary percutaneous coronary intervention (PCI). The aim of the present study was to compare door-to-balloon time (D2B) of ECG guided immediate infarct-related artery (IRA) PCI with traditional complete coronary angiography followed by PCI for the treatment of ST segment elevation myocardial infarction (STEMI) patients. Primary endpoint is door to device (D2D) time. Secondary end-points are: puncture to device (P2D) time,first medical contact to device (FMC2D) time,incidence of radial artery spasm and occlusion, contrast amount, fluoroscopy time, cumulative air kerma(CAK) and dose area product(DAP).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| culprit vessel intervention | Experimental | Procedure: culprit vessel interventionculprit vessel PCI prior to contralateral angiography using a single transradial guiding catheter |
| traditional approach | Active comparator | Procedure: traditional approachcomplete coronary angiography followed by guiding catheter selection for culprit vessel PCI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 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 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 |
|---|---|---|
| culprit vessel interventionECG guided immediate culprit vessel intervention using a single transradial guiding catheter such as MAC or JL 3.5 | Procedure or surgery | culprit vessel intervention |
| traditional approachsingle diagnostic catheter for complete coronary angiography and guiding catheter selection for PCI | Procedure or surgery | traditional approach |
Primary outcome
door to device (D2D) time
Time frame: 24hours
time patient's arrival at our hospital to first device (balloon,aspiration catheter or stent) use
6 secondary outcomes
puncture to device (P2D) time
Time frame: 24hours
first medical contact to device (FMC2D) time
Time frame: 24hours
incidence of radial artery spasm
Time frame: during the procedure (time from the guide catheter inserted to guide catheter removed)
incidence of radial artery occlusion
Time frame: inhospital (an expected average of 5 days),30day,12month
fluoroscopy time
Time frame: 1 hour
cumulative air kerma(CAK) and dose area product(DAP).
Time frame: 1 hour
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 1 Jun 2022.
- Derived from this study: PubMed 36386357Guo J, Wang G, Li Z, Liu Z, Wang Y, Wang S, Wang Y, Wu Y, Wang H, Wang Y, Zhang L, Hua Q. Culprit vessel revascularization first with primary use of a dedicated transradial guiding catheter to reduce door to balloon time in primary percutaneous coronary intervention. Front Cardiovasc Med. 2022 Oct 28;9:1022488. doi: 10.3389/fcvm.2022.1022488. eCollection 2022.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing culprit vessel intervention and traditional approach in people with Myocardial Infarction, run by Beijing Luhe Hospital at 2 sites 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 7 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 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
door to device (D2D) time (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 NCT03272451, 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 1 Jun 2022.