Coronary Artery DiseaseRIPC-DCBNCT04766749
Remote Ischemic Preconditioning on the Prognosis of Patients With Elective PCI Using Drug-coated Balloon
A study testing RIPC in people with Coronary Artery Disease, run by Henan Institute of Cardiovascular Epidemiology at 1 site in China.
Trial summary
Drug-coated balloon is being used more and more widely for the advantage of intervention without implantation. But the balloon needs to be released long enough to be effective. Prolonged balloon dilation resulting in the cessation of blood flow in the distal vessels, especially large vessels, may result in severe… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- RIPC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 430 participants
- Where
- 1 siteChina
- Study dates
- 24 Feb 2021to 20 May 2023
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diameter stenosis>=50% by visual estimation intend to undergo drug-coated balloon implantation
- Target vessel diameter> 2.5mm
Who cannot join
- Chronic Total Obstructive lesion
- Diagnose patients with acute myocardial infarction <24 hours
- Can't tolerate or not suitable for RIPC
- Severe hepatic and renal insufficiency
- Expected survival <1 year
- Severe calcification needing rotational atherectomy
- Intolerable to dual antiplatelet therapy
Trial locations and contacts
1 site in 1 country.
About this study
Drug-coated balloon is being used more and more widely for the advantage of intervention without implantation.
But the balloon needs to be released long enough to be effective. Prolonged balloon dilation resulting in the cessation of blood flow in the distal vessels, especially large vessels, may result in severe ischemia in the patient.
RIPC can enhance patients' tolerance to ischemic events, so we believe that RIPC application before the use of drug balloon for PCI can improve patients' ischemic symptoms, thus increasing the release time of drug balloon and improving the effect.
Read the detailed description
Some patients receiving PCI cannot tolerate the symptoms of myocardial ischemia caused by the release of the drug balloon for a long time and even lead to the occurrence of adverse events.RIPC was found to improve tolerance to myocardial ischemia in patients.
At the same time, it can open collateral circulation and improve the tolerance of myocardial ischemia in patients.Therefore, this study designed a parallel control group. The experimental group was treated with RIPC before PCI, while the control group was not treated before PCI.
The operator does not know whether the patient has undergone RIPC or not, and the operator decides the time of drug balloon release according to the symptoms of the patient during the operation.Angiography was performed at 6 months, and QCA was used to determine late lumen loss at 1 year.The 1-year incidence of target lesion failure events was assessed.
- Conditions
- Coronary Artery Disease
- Being tested
- RIPC
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RIPCOther
RIPC is delivered with a standard blood pressure cuff placed on the upper thigh. The cuffs are inflated to 200 mm Hg and keep inflated for 5 minutes,Then deflated to 0 mmHg and keep uninflated for 5 minutes, This cycle is repeated four times
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | 40 minutes before PCI by the nurse to the patient RIPC operation (RIPC is delivered with a standard blood pressure cuff placed on the upper thigh. The cuffs are inflated to 200 mm Hg and keep inflated for 5 minutes,Then deflated to 0 mmHg and keep uninflated for 5 minutes, This cycle is repeated four times), and then do regular PCI operation Receives: Other: RIPC |
| Control | No intervention | A standard cuff is placed on the patient's thigh by the nurse 40 minutes before PCI but it is not inflated. PCI is performed 40 minutes later |
What is being measured
The primary outcome is the main question the study is designed to answer.
TLF
TLF, a composite of cardiac death, target vessel-related myocardial infarction (MI; not clearly attributed to a nontarget vessel and excluding periprocedural MI), or clinically indicated target lesion revascularization (TLR)
Measured: 12 months
Secondary outcomes (2)
Late lumen loss of target vessel（mm）
Late Lumen Loss of target vessel（mm） by Quantitative Coronary Angiography (QCA).
Measured: 6 months
DCB expansion time
We hypothesis/speculated that the RIPC group had better ischemia tolerance, so the balloon dilation time was longer than the control group.
But the total time for all patients is less than 120 seconds
Measured: less than 120 seconds (On the 1 day of PCI)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start24 Feb 2021
- Primary completion20 Feb 2022
- Study completion20 May 2023
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 Coronary Artery DiseaseStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 430 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henan Institute of Cardiovascular Epidemiology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muwei Li, MD, Study chair, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04766749
- Sponsor's protocol ID
- HenanICE202104
- Acronym
- RIPC-DCB
- Status last verified
- Dec 2023
- First submitted
- 10 Feb 2021
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: After the results are published, researchers can obtain IPD from the responsible person on reasonable request
Publications
Zhao Z, Yu H, Nie M, Li X, Li M. Remote Ischemic Preconditioning Before Drug-Coated Balloon Implantation can Improve the Long-Term Prognosis of Patients with CAD. Rev Cardiovasc Med. 2024 Mar 27;25(4):116. doi: 10.31083/j.rcm2504116. eCollection 2024 Apr.
PubMed 39076569
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Ischemic Preconditioning on the Prognosis of Patients With Elective PCI Using Drug-coated Balloon
- ClinicalTrials.gov ID
- NCT04766749
- Acronym / sponsor ID
- RIPC-DCB / HenanICE202104
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 430 participants (actual)
- Lead sponsor
- Henan Institute of Cardiovascular EpidemiologyUniversity, hospital or other
- Study start
- 24 Feb 2021 (actual)
- Primary completion
- 20 Feb 2022 (actual)
- Study completion
- 20 May 2023 (actual)
- First posted
- 23 Feb 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.
Drug-coated balloon is being used more and more widely for the advantage of intervention without implantation.
But the balloon needs to be released long enough to be effective. Prolonged balloon dilation resulting in the cessation of blood flow in the distal vessels, especially large vessels, may result in severe ischemia in the patient.
RIPC can enhance patients' tolerance to ischemic events, so we believe that RIPC application before the use of drug balloon for PCI can improve patients' ischemic symptoms, thus increasing the release time of drug balloon and improving the effect.
Detailed description
Some patients receiving PCI cannot tolerate the symptoms of myocardial ischemia caused by the release of the drug balloon for a long time and even lead to the occurrence of adverse events.RIPC was found to improve tolerance to myocardial ischemia in patients.
At the same time, it can open collateral circulation and improve the tolerance of myocardial ischemia in patients.Therefore, this study designed a parallel control group. The experimental group was treated with RIPC before PCI, while the control group was not treated before PCI.
The operator does not know whether the patient has undergone RIPC or not, and the operator decides the time of drug balloon release according to the symptoms of the patient during the operation.Angiography was performed at 6 months, and QCA was used to determine late lumen loss at 1 year.The 1-year incidence of target lesion failure events was assessed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: RIPC40 minutes before PCI by the nurse to the patient RIPC operation (RIPC is delivered with a standard blood pressure cuff placed on the upper thigh. The cuffs are inflated to 200 mm Hg and keep inflated for 5 minutes,Then deflated to 0 mmHg and keep uninflated for 5 minutes, This cycle is repeated four times), and then do regular PCI operation |
| Control | No intervention | –A standard cuff is placed on the patient's thigh by the nurse 40 minutes before PCI but it is not inflated. PCI is performed 40 minutes later |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diameter stenosis>=50% by visual estimation intend to undergo drug-coated balloon implantation
- Target vessel diameter> 2.5mm
Key exclusion criteria (7 listed)
- Chronic Total Obstructive lesion
- Diagnose patients with acute myocardial infarction <24 hours
- Can't tolerate or not suitable for RIPC
- Severe hepatic and renal insufficiency
- Expected survival <1 year
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 |
|---|---|---|
| RIPCRIPC is delivered with a standard blood pressure cuff placed on the upper thigh. The cuffs are inflated to 200 mm Hg and keep inflated for 5 minutes,Then deflated to 0 mmHg and keep uninflated for 5 minutes, This cycle is repeated four times | Other | Experimental |
Primary outcome
TLF
Time frame: 12 months
TLF, a composite of cardiac death, target vessel-related myocardial infarction (MI; not clearly attributed to a nontarget vessel and excluding periprocedural MI), or clinically indicated target lesion revascularization (TLR)
2 secondary outcomes
Late lumen loss of target vessel（mm）
Time frame: 6 months
DCB expansion time
Time frame: less than 120 seconds (On the 1 day of PCI)
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 7 Dec 2023.
- Derived from this study: PubMed 39076569Zhao Z, Yu H, Nie M, Li X, Li M. Remote Ischemic Preconditioning Before Drug-Coated Balloon Implantation can Improve the Long-Term Prognosis of Patients with CAD. Rev Cardiovasc Med. 2024 Mar 27;25(4):116. doi: 10.31083/j.rcm2504116. eCollection 2024 Apr.
- Individual participant dataSharing planned: No. After the results are published, researchers can obtain IPD from the responsible person on reasonable request
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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.
Muwei Li, MD study chair
Chinese Academy of Medical Sciences, Fuwai 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 RIPC in people with Coronary Artery Disease, run by Henan Institute of Cardiovascular Epidemiology 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 2 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 7 Dec 2023. 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?
TLF (time frame: 12 months). 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 NCT04766749, 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 7 Dec 2023.