Coronary Artery Bypass GraftingIMPROVENCT06141525
Safety and Efficacy of Remote Ischemic Conditioning for Patients Taking Off-pump Coronary Artery Bypass Grafting
A study testing Remote ischemic conditioning in people with Coronary Artery Bypass Grafting and Remote Ischemic Conditioning, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
Remote ischemic conditioning (RIC) is the process of repeated ischemia and reperfusion in the peripheral vessels, which is proved in reducing IRI in vital organs. This IMPROVE trial plans to enroll 648 patients who are diagnosed with coronary artery disease and are going to take off-pump CABG in five centers in China… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Coronary Artery Bypass Grafting, Remote Ischemic Conditioning, Ischemia-Reperfusion Injury
- What is being tested?
- Remote ischemic conditioning
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 648 participants
- Where
- 1 siteChina
- Study dates
- 22 Nov 2023to 31 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with coronary artery disease and require off-pump CABG surgery.
- Between 18 and 75 years old;
- Normal left ventricular systolic function (ejection fraction >40%) and left ventricular end-diastolic internal diameter (<60 mm) in the cardiac ultrasound tests;
- No or mild heart valve and great vessel abnormalities which do not require surgical intervention;
- Participants or their authorized relatives agree to participate in the clinical trial and sign the informed consent.
Who cannot join
- Severe tissue injuries.
- Myalgia, fractures and other peripheral vascular lesions.
- Bypass graft being the radial artery.
- Stenosis or severe malformations of the subclavian, jugular and femoral arteries and veins.
- Previous vagus nerve trunk dissection or vagus nerve block surgery.
- Other surgical operations at the same time.
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- Patients with pre-existing severe cardiac insufficiency, acute coronary syndromes, malignant hypertension and cardiogenic shock.
- Severe coagulation abnormality or severe anemia.
- Severe mental disorder.
- Malignant tumors.
- Pregnant or lactating.
- Increased risk of treatment for patients, according to investigators.
- Refuse to sign the informed consent form.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Xi'an Jiantong University
Xi'an, Shaanxi, 710061
Guoliang Li, +862985323865, liguoliang_med@163.com
Yang Yan, +862985323865, yangyan3@xjtu.edu.cn
About this study
Official title: Safety and Efficacy of Remote Ischemic Conditioning for Patients Taking Off-pump Coronary Artery Bypass Grafting (IMPROVE): A National, Multi-center, Randomized, Controlled, Open-label, Blinded-endpoint Trial
Remote ischemic conditioning (RIC) is the process of repeated ischemia and reperfusion in the peripheral vessels, which is proved in reducing IRI in vital organs. This IMPROVE trial plans to enroll 648 patients who are diagnosed with coronary artery disease and are going to take off-pump CABG in five centers in China, to access whether RIC can and improve short-term prognosis.
Read the detailed description
Remote ischemic conditioning (RIC) is the process of repeated ischemia and reperfusion in the peripheral vessels, which is proved in reducing IRI in vital organs. However, the effect of RIC in patients undergoing off-pump CABG is still unclear. This IMPROVE trial plans to enroll 648 patients who are diagnosed with coronary artery disease and are going to take off-pump CABG in five centers in China, to access whether RIC can and improve short-term prognosis. Patients will be randomly assigned into RIC group and control group. The primary outcome is the occurrence of the major adverse cardiovascular and cerebrovascular events (MACCE) within the 3-month follow-up. The MACCE is defined as all-cause of death, myocardial infarction, stroke and coronary revascularization surgery.
- Conditions
- Coronary Artery Bypass Grafting, Remote Ischemic Conditioning, Ischemia-Reperfusion Injury
- Being tested
- Remote ischemic conditioning
- Medical subject headings
- Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischemic conditioningDevice
An automatic programmed blood pressure cuffs will be placed on two upper limbs of the patient and pressurized to 200 mmHg (or at least 20 mmHg higher than the systolic blood pressure if the systolic blood pressure of the patient is above 180 mmHg) with 5 minutes of pressurization and 5 minutes of rest. One pressurization with rest is deemed as one cycle (10 minutes), and 4 cycles will be performed each time (for a total of 40 minutes).
| Study group | Role | What they receive |
|---|---|---|
| RIC group | Experimental | In the RIC group, patients will undergo RIC training in the 3 days before and 7 days after the CABG surgery. Receives: Device: Remote ischemic conditioning |
| Control group | No intervention | In the control group, a blood pressure cuff, same as the cuff in the RIC group, will be placed on both upper arms of the patients but only pressurized to 60 mmHg. The rest of the procedures will be the same. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of MACCE
MACCE includes all-cause of death, myocardial infarction, stroke and coronary revascularization surgery. The data will be obtained at 3-month follow-up, according to medical records of all patients.
Measured: 3-month after the enrollment.
Secondary outcomes (7)
The incidence of all-cause of death
The data will be obtained at 3-month follow-up, according to medical records of all patients.
Measured: 3-month after the enrollment.
The incidence of myocardial infarction
The data will be obtained at 3-month follow-up, according to medical records of all patients.
Measured: 3-month after the enrollment.
The incidence of stroke
The data will be obtained at 3-month follow-up, according to medical records of all patients.
Measured: 3-month after the enrollment.
The incidence of coronary revascularization surgery
The data will be obtained at 3-month follow-up, according to medical records of all patients.
Measured: 3-month after the enrollment.
The length of postoperative ICU-stay
This outcome includes all days in ICU after the operation of all patients. The data will be recorded from the medical records.
Measured: About 3 days after the operation.
The total length of stay in the hospital
This outcome includes all days in the hospital of all patients. The data will be recorded from the medical records.
Measured: About 7days after the operation.
Changes of 6-min walk test results
6-min walk test will be measured by stopwatches and metre rulers. The test assesses the overall response of all systems involved in exercise by measuring the distance the patient walks rapidly on a flat, hard surface over a period of six minutes.
Measured: 3-month after the enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start22 Nov 2023
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Mar 2029 (estimated)
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 Bypass GraftingStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 648 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Anzhen Hospital, People's Hospital of Qinghai Province, The Second Hospital of Yulin City, Baoji Central Hospital
- Responsible party
- Sponsor
- Investigators
- Yang Yan, Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06141525
- Sponsor's protocol ID
- XJTU1AF2022LSK-427-01
- Acronym
- IMPROVE
- Status last verified
- Jul 2024
- First submitted
- 15 Nov 2023
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yan Y, Zhao C, Niu J, Yan P, Li J, Wang D, Li G. Rationale and Design of the IMPROVE Trial: A Multicenter, Randomized, Controlled, Open-label, Blinded-endpoint Trial Assessing the Efficacy of Remote Ischemic Conditioning in Patients Undergoing Off-Pump Coronary Artery Bypass Grafting. Adv Ther. 2024 Jul;41(7):3003-3012. doi: 10.1007/s12325-024-02836-7. Epub 2024 Apr 15.
PubMed 38616242
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Remote Ischemic Conditioning for Patients Taking Off-pump Coronary Artery Bypass Grafting (IMPROVE): A National, Multi-center, Randomized, Controlled, Open-label, Blinded-endpoint Trial
- ClinicalTrials.gov ID
- NCT06141525
- Acronym / sponsor ID
- IMPROVE / XJTU1AF2022LSK-427-01
- Conditions
- Coronary Artery Bypass Grafting, Remote Ischemic Conditioning, Ischemia-Reperfusion Injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 648 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- Beijing Anzhen Hospital, People's Hospital of Qinghai Province, The Second Hospital of Yulin City, Baoji Central Hospital
- Study start
- 22 Nov 2023 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 21 Nov 2023 (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.
Remote ischemic conditioning (RIC) is the process of repeated ischemia and reperfusion in the peripheral vessels, which is proved in reducing IRI in vital organs. This IMPROVE trial plans to enroll 648 patients who are diagnosed with coronary artery disease and are going to take off-pump CABG in five centers in China, to access whether RIC can and improve short-term prognosis.
Detailed description
Remote ischemic conditioning (RIC) is the process of repeated ischemia and reperfusion in the peripheral vessels, which is proved in reducing IRI in vital organs. However, the effect of RIC in patients undergoing off-pump CABG is still unclear. This IMPROVE trial plans to enroll 648 patients who are diagnosed with coronary artery disease and are going to take off-pump CABG in five centers in China, to access whether RIC can and improve short-term prognosis. Patients will be randomly assigned into RIC group and control group. The primary outcome is the occurrence of the major adverse cardiovascular and cerebrovascular events (MACCE) within the 3-month follow-up. The MACCE is defined as all-cause of death, myocardial infarction, stroke and coronary revascularization surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIC group | Experimental | Device: Remote ischemic conditioningIn the RIC group, patients will undergo RIC training in the 3 days before and 7 days after the CABG surgery. |
| Control group | No intervention | –In the control group, a blood pressure cuff, same as the cuff in the RIC group, will be placed on both upper arms of the patients but only pressurized to 60 mmHg. The rest of the procedures will be the same. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with coronary artery disease and require off-pump CABG surgery.
- Between 18 and 75 years old;
- Normal left ventricular systolic function (ejection fraction >40%) and left ventricular end-diastolic internal diameter (<60 mm) in the cardiac ultrasound tests;
- No or mild heart valve and great vessel abnormalities which do not require surgical intervention;
- Participants or their authorized relatives agree to participate in the clinical trial and sign the informed consent.
Key exclusion criteria (13 listed)
- Severe tissue injuries.
- Myalgia, fractures and other peripheral vascular lesions.
- Bypass graft being the radial artery.
- Stenosis or severe malformations of the subclavian, jugular and femoral arteries and veins.
- Previous vagus nerve trunk dissection or vagus nerve block surgery.
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 |
|---|---|---|
| Remote ischemic conditioningAn automatic programmed blood pressure cuffs will be placed on two upper limbs of the patient and pressurized to 200 mmHg (or at least 20 mmHg higher than the systolic blood pressure if the systolic blood pressure of the patient is above 180 mmHg) with 5 minutes of pressurization and 5 minutes of rest. One pressurization with rest is deemed as one cycle (10 minutes), and 4 cycles will be performed each time (for a total of 40 minutes). | Device | RIC group |
Primary outcome
The incidence of MACCE
Time frame: 3-month after the enrollment.
MACCE includes all-cause of death, myocardial infarction, stroke and coronary revascularization surgery. The data will be obtained at 3-month follow-up, according to medical records of all patients.
7 secondary outcomes
The incidence of all-cause of death
Time frame: 3-month after the enrollment.
The incidence of myocardial infarction
Time frame: 3-month after the enrollment.
The incidence of stroke
Time frame: 3-month after the enrollment.
The incidence of coronary revascularization surgery
Time frame: 3-month after the enrollment.
The length of postoperative ICU-stay
Time frame: About 3 days after the operation.
The total length of stay in the hospital
Time frame: About 7days after the operation.
Changes of 6-min walk test results
Time frame: 3-month after the enrollment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Derived from this study: PubMed 38616242Yan Y, Zhao C, Niu J, Yan P, Li J, Wang D, Li G. Rationale and Design of the IMPROVE Trial: A Multicenter, Randomized, Controlled, Open-label, Blinded-endpoint Trial Assessing the Efficacy of Remote Ischemic Conditioning in Patients Undergoing Off-Pump Coronary Artery Bypass Grafting. Adv Ther. 2024 Jul;41(7):3003-3012. doi: 10.1007/s12325-024-02836-7. Epub 2024 Apr 15.
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Coronary Artery Bypass Graft (CABG)
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.
Yang Yan principal investigator
First Affiliated Hospital Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote ischemic conditioning in people with Coronary Artery Bypass Grafting and Remote Ischemic Conditioning, run by First Affiliated Hospital Xi'an Jiaotong 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 5 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 12 Jul 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yang Yan (+86.29.85323869, yangyan3@xjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of MACCE (time frame: 3-month after the enrollment.). 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 NCT06141525, 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 12 Jul 2024.