Acute Myocardial InfarctionNCT05044806
Effect of Perioperative Ultrasound-guided Remote Ischemic Conditioning on Acute Myocardial Infarction
A study testing Ultrasound-guided remote ischemic conditioning, Traditional remote ischemic conditioning and Percutaneous coronary intervention in people with Acute Myocardial Infarction, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
Acute myocardial infarction (AMI) is an event of myocardial necrosis caused by myocardial ischemia. Although the incidence and economic burden of AMI has declined in high-income countries, the incidence rate of AMI in China has increased dramatically over the past several decades. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Ultrasound-guided remote ischemic conditioning, Traditional remote ischemic conditioning and Percutaneous coronary intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to Dec 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly developed ST segment elevation myocardial infarction (STEMI) and non-ST segment elevation myocardial infarction (non-STEMI) according to clinical symptoms, ECG and laboratory confirmation;
- Patients aged 18-80 yr;
- Scheduled for PCI;
- With normal cognitive function indicated by MMSE score >16 and able to cooperate with intervention;
- Agreed to participate and signed the consent form.
Who cannot join
- Previous STEMI or non-STEMI;
- Previous coronary artery bypass grafting (CABG) ;
- Developed thrombolysis within the last 30 days;
- Cardiogenic shock history;
- Persistent atrial fibrillation history;
- Severe complications (e.g. ventricular septal rupture, free wall rupture or acute severe mitral regurgitation) warrant surgical interventions;
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- Uncontrolled hypertension (systolic blood pressure >160mmHg or diastolic blood pressure >100mmHg);
- With peripheral neuropathy, peripheral artery disease, superficial thrombophlebitis or deep vein thrombosis;
- Other severe systemic diseases;
- Participated in other trials previously.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210009
Yu Zheng, M.D., 86 17327081766, zhengyu8710@163.com
Xiao Lu
About this study
Official title: Effect of Perioperative Ultrasound-guided Remote Ischemic Conditioning on Myocardial Injury in Acute Myocardial Infarction Patients Undergoing Percutaneous Coronary Intervention: a Prospective Cohort Study
Acute myocardial infarction (AMI) is an event of myocardial necrosis caused by myocardial ischemia. Although the incidence and economic burden of AMI has declined in high-income countries, the incidence rate of AMI in China has increased dramatically over the past several decades. Initial medical therapy combined with primary percutaneous coronary intervention (PCI) is currently the most important advance in restoring coronary perfusion. Timely reperfusion therapy may halt the progress of necrosis and preserve viable tissue; however, it can also induce myocardial injury and cause cardiomyocyte death, a phenomenon called myocardial ischemia reperfusion injury (IRI), which can increase final myocardial infarct size by up to 50%. Unfortunately, there is no effective intervention for preventing IRI to date, though an improved understanding of the pathophysiology of IRI has led to the suggestion of several innovative therapeutic strategies with the potential for reducing unintended negative side effects of reperfusion therapy in AMI patients. Whether there is a therapeutic intervention that can effectively and safely reduce myocardial infarct size and cardiac mortality has been intensely explored over the years. Against this backdrop, a phenomenon called remote ischemic conditioning (RIC) has long been discussed as a potential approach to address the above issues. The purpose of present study is to investigate the efficacy of perioperative remote ischemic conditioning delivered at individual timepoints (e.g., pre-, per- and post-PCI) on myocardial injury in patients with AMI.
Read the detailed description
RIC refers to a cardio-protective effect induced by non-invasively applying cycles of physiological ischemia and reperfusion to remote body parts, e.g., through application of a blood pressure cuff or similar device to a remote limb. The actual molecular biological mechanisms underlying RIC may be attributed to a neuro-hormonal pathway conveying a cardio-protective signal from a local limb to the remote heart. The safety of RIC delivered at a single time point (e.g., pre-, per- or post-PCI) in AMI patients has been well established in a number of clinical trials. However, the RIC's cardio-protective effects remain under debate, especially for RIC programs delivered at individual timepoints during operative period (pre-, per- and post-PCI). Besides, in these trials, the cuff compression pressure of RIC protocol is mostly 200mmHg or 20-50mmHg above systolic pressure. Peripheral vascular ischemia effects of upper limbs are different under different pressure conditions. However, no study has been conducted to investigate the clinical effects of RIC training under different pressure conditions. In the present study, ultrasound is used to determine the brachial artery total occlusion pressure (TOP), which is regarded as optimal pressure of flow restriction in ischemic exercise training. And patients in the ultrasound-guided RIC group will receive RIC applying TOP as cuff compression pressure, while compression pressure applied in traditional RIC group patients is 20mmHg above systolic pressure. The purpose of present study is to investigate the effect of perioperative RIC delivered across the full disease cycle, and compare the effects of ultrasound-guided RIC protocol and traditional RIC protocol on cardiac enzyme infarct size, cardiac function, cardiopulmonary endurance and quality of life in patients with AMI.
- Conditions
- Acute Myocardial Infarction
- Being tested
- Ultrasound-guided remote ischemic conditioning, Traditional remote ischemic conditioning, Percutaneous coronary intervention
- Keywords
- Remote ischemic conditioning, Percutaneous coronary intervention, Infarction, Myocardial injury, Acute myocardial infarction
- Medical subject headings
- Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided remote ischemic conditioningOther
Before conducting RIC, Doppler ultrasound was used to measure the total occlusion pressure (TOP) of brachial artery, which was then determined as the cuff inflation pressure during RIC. The RIC program encompasses four main components of (1) three cycles of remote ischemic pre-conditioning which will be delivered right after the eligibility check and informed consent form signature before PCI; (2) one cycle of remote ischemic per-conditioning, which will be delivered during PCI; (3) three cycles of remote ischemic post-conditioning, which will be delivered within 10 min after PCI; and (4) two sessions per day of remote ischemic post-conditioning which will start on post-operative day 1 and last till hospital discharge. The remote ischemic pre- and post-conditioning share the RIC protocol, which comprises three 3 min cycles of RIC with 3 min intervals of reperfusion in between, while only one single 3 min cycle will be delivered for the remote ischemic per-conditioning.
Traditional remote ischemic conditioningOther
The RIC program encompasses four main components of (1)three cycles of remote ischemic pre-conditioning which will be delivered right after the eligibility check and informed consent form signature before PCI; (2)one cycle of remote ischemic per-conditioning, which will be delivered during PCI; (3)three cycles of remote ischemic post-conditioning, which will be delivered within 10 min after PCI; and (4) two sessions per day of remote ischemic post-conditioning which will start on post-operative day 1 and last till hospital discharge. The remote ischemic pre- and post-conditioning share the RIC protocol, which comprises three 3 min cycles of upper limb ischemia on the arm that is opposite to the PCI side with 3 min intervals of reperfusion in between delivered by an automated cuff inflation/deflation device, while only one single 3 min cycle will be delivered for the remote ischemic per-conditioning. The pressure applied during cuff inflation is 20 mmHg above systolic blood pressure.
Percutaneous coronary interventionProcedure or surgery
Also called coronary angioplasty
Percutaneous coronary intervention (PCI) will be performed by a cardiologist or doctor who specializes in the heart to open coronary arteries that are narrowed or blocked by the buildup of atherosclerotic plaque. PCI requires cardiac catheterization, which is the insertion of a catheter tube, and live x rays helping to guide the catheter into the heart to inject special contrast dye that will highlight the blockage. To open a blocked artery, another catheter will be inserted over a guidewire, a balloon will be inflated at the tip of that catheter, and a small mesh tube called a stent may be put in the artery to help keep the artery open. After PCI, the catheters will be removed, the opening on the wrist or groin will be closed and bandaged.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-guided-RIC group | Experimental | Patients in the ultrasound-guided-RIC group will receive percutaneous coronary intervention (PCI), usual pharmacotherapy and pre-, per-, and post-operative ultrasound-guided remote ischemic conditioning (RIC). The pressure applied during cuff inflation is total occlusion pressure (TOP) determined with ultrasound measurement. Receives: Other: Ultrasound-guided remote ischemic conditioning; Procedure: Percutaneous coronary intervention |
| Traditional RIC group | Experimental | Patients in the traditional RIC group will receive PCI, usual pharmacotherapy and pre-, per-, and post-operative traditional RIC. The pressure applied during cuff inflation is 20 mmHg above systolic blood pressure. Receives: Other: Traditional remote ischemic conditioning; Procedure: Percutaneous coronary intervention |
| Control group | Other | Patients in the control group will receive PCI and usual pharmacotherapy. Receives: Procedure: Percutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infarct size
Cardiac enzyme infarct size is assessed as 72-hour area under the curve (AUC) cardiac troponin T (cTnT) release.
Measured: During 0-72 hours after surgery
Secondary outcomes (9)
Plasma concentration of myocardial infarction-related key biomarkers (PCMIKB)
PCMIKB will be reflected with concentration of cardiac troponin T (cTnT).
Measured: Three days after surgery
B-type natriuretic peptide （BNP）
The concentration of BNP will be measured during perioperative period.
Measured: Three days after surgery
Left ventricular ejection fraction (LVEF)
Left ventricular ejection fraction (LVEF) will be measured with two dimensional echocardiography.
Measured: One week after surgery
Left ventricular end-diastolic volume (LVEDV)
Left ventricular end-diastolic volume (LVEDV) will be measured with two dimensional echocardiography.
Measured: One week after surgery
Left ventricular end systolic volume (LVESV).
Left ventricular end systolic volume (LVESV) will be measured with two dimensional echocardiography.
Measured: One week after surgery
Cardiopulmonary endurance
Cardiopulmonary endurance will be measured with the 6-min walking test (6MWT).
Measured: Three days after surgery
Blood pressure
Systolic and diastolic blood pressure will be monitored before and after training.
Measured: When postoperative RIC is finished（within 10 minutes after PCI）
Heart rate
Heart rate will be monitored before and after training.
Measured: When postoperative RIC is finished（within 10 minutes after PCI）
Total hospital length of stay (LOS)
LOS accounts for total hospital LOS in both acute hospital and rehabilitation hospital after PCI.
Measured: Up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start1 Sep 2021
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Zheng, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Xiao Lu, M.D., Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05044806
- Sponsor's protocol ID
- RIC
- Status last verified
- Nov 2021
- First submitted
- 1 Sep 2021
- Last updated
- 11 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Perioperative Ultrasound-guided Remote Ischemic Conditioning on Myocardial Injury in Acute Myocardial Infarction Patients Undergoing Percutaneous Coronary Intervention: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05044806
- Acronym / sponsor ID
- RIC
- Conditions
- Acute Myocardial Infarction
- Keywords
- Remote ischemic conditioning, Percutaneous coronary intervention, Infarction, Myocardial injury, Acute myocardial infarction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 16 Sep 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.
Acute myocardial infarction (AMI) is an event of myocardial necrosis caused by myocardial ischemia. Although the incidence and economic burden of AMI has declined in high-income countries, the incidence rate of AMI in China has increased dramatically over the past several decades. Initial medical therapy combined with primary percutaneous coronary intervention (PCI) is currently the most important advance in restoring coronary perfusion. Timely reperfusion therapy may halt the progress of necrosis and preserve viable tissue; however, it can also induce myocardial injury and cause cardiomyocyte death, a phenomenon called myocardial ischemia reperfusion injury (IRI), which can increase final myocardial infarct size by up to 50%. Unfortunately, there is no effective intervention for preventing IRI to date, though an improved understanding of the pathophysiology of IRI has led to the suggestion of several innovative therapeutic strategies with the potential for reducing unintended negative side effects of reperfusion therapy in AMI patients. Whether there is a therapeutic intervention that can effectively and safely reduce myocardial infarct size and cardiac mortality has been intensely explored over the years. Against this backdrop, a phenomenon called remote ischemic conditioning (RIC) has long been discussed as a potential approach to address the above issues. The purpose of present study is to investigate the efficacy of perioperative remote ischemic conditioning delivered at individual timepoints (e.g., pre-, per- and post-PCI) on myocardial injury in patients with AMI.
Detailed description
RIC refers to a cardio-protective effect induced by non-invasively applying cycles of physiological ischemia and reperfusion to remote body parts, e.g., through application of a blood pressure cuff or similar device to a remote limb. The actual molecular biological mechanisms underlying RIC may be attributed to a neuro-hormonal pathway conveying a cardio-protective signal from a local limb to the remote heart. The safety of RIC delivered at a single time point (e.g., pre-, per- or post-PCI) in AMI patients has been well established in a number of clinical trials. However, the RIC's cardio-protective effects remain under debate, especially for RIC programs delivered at individual timepoints during operative period (pre-, per- and post-PCI). Besides, in these trials, the cuff compression pressure of RIC protocol is mostly 200mmHg or 20-50mmHg above systolic pressure. Peripheral vascular ischemia effects of upper limbs are different under different pressure conditions. However, no study has been conducted to investigate the clinical effects of RIC training under different pressure conditions. In the present study, ultrasound is used to determine the brachial artery total occlusion pressure (TOP), which is regarded as optimal pressure of flow restriction in ischemic exercise training. And patients in the ultrasound-guided RIC group will receive RIC applying TOP as cuff compression pressure, while compression pressure applied in traditional RIC group patients is 20mmHg above systolic pressure. The purpose of present study is to investigate the effect of perioperative RIC delivered across the full disease cycle, and compare the effects of ultrasound-guided RIC protocol and traditional RIC protocol on cardiac enzyme infarct size, cardiac function, cardiopulmonary endurance and quality of life in patients with AMI.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-guided-RIC group | Experimental | Other: Ultrasound-guided remote ischemic conditioning, Procedure: Percutaneous coronary interventionPatients in the ultrasound-guided-RIC group will receive percutaneous coronary intervention (PCI), usual pharmacotherapy and pre-, per-, and post-operative ultrasound-guided remote ischemic conditioning (RIC). The pressure applied during cuff inflation is total occlusion pressure (TOP) determined with ultrasound measurement. |
| Traditional RIC group | Experimental | Other: Traditional remote ischemic conditioning, Procedure: Percutaneous coronary interventionPatients in the traditional RIC group will receive PCI, usual pharmacotherapy and pre-, per-, and post-operative traditional RIC. The pressure applied during cuff inflation is 20 mmHg above systolic blood pressure. |
| Control group | Other | Procedure: Percutaneous coronary interventionPatients in the control group will receive PCI and usual pharmacotherapy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Newly developed ST segment elevation myocardial infarction (STEMI) and non-ST segment elevation myocardial infarction (non-STEMI) according to clinical symptoms, ECG and laboratory confirmation;
- Patients aged 18-80 yr;
- Scheduled for PCI;
- With normal cognitive function indicated by MMSE score >16 and able to cooperate with intervention;
- Agreed to participate and signed the consent form.
Key exclusion criteria (10 listed)
- Previous STEMI or non-STEMI;
- Previous coronary artery bypass grafting (CABG) ;
- Developed thrombolysis within the last 30 days;
- Cardiogenic shock history;
- Persistent atrial fibrillation history;
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 |
|---|---|---|
| Ultrasound-guided remote ischemic conditioningBefore conducting RIC, Doppler ultrasound was used to measure the total occlusion pressure (TOP) of brachial artery, which was then determined as the cuff inflation pressure during RIC. The RIC program encompasses four main components of (1) three cycles of remote ischemic pre-conditioning which will be delivered right after the eligibility check and informed consent form signature before PCI; (2) one cycle of remote ischemic per-conditioning, which will be delivered during PCI; (3) three cycles of remote ischemic post-conditioning, which will be delivered within 10 min after PCI; and (4) two sessions per day of remote ischemic post-conditioning which will start on post-operative day 1 and last till hospital discharge. The remote ischemic pre- and post-conditioning share the RIC protocol, which comprises three 3 min cycles of RIC with 3 min intervals of reperfusion in between, while only one single 3 min cycle will be delivered for the remote ischemic per-conditioning. | Other | Ultrasound-guided-RIC group |
| Traditional remote ischemic conditioningThe RIC program encompasses four main components of (1)three cycles of remote ischemic pre-conditioning which will be delivered right after the eligibility check and informed consent form signature before PCI; (2)one cycle of remote ischemic per-conditioning, which will be delivered during PCI; (3)three cycles of remote ischemic post-conditioning, which will be delivered within 10 min after PCI; and (4) two sessions per day of remote ischemic post-conditioning which will start on post-operative day 1 and last till hospital discharge. The remote ischemic pre- and post-conditioning share the RIC protocol, which comprises three 3 min cycles of upper limb ischemia on the arm that is opposite to the PCI side with 3 min intervals of reperfusion in between delivered by an automated cuff inflation/deflation device, while only one single 3 min cycle will be delivered for the remote ischemic per-conditioning. The pressure applied during cuff inflation is 20 mmHg above systolic blood pressure. | Other | Traditional RIC group |
| Percutaneous coronary interventionAlso: coronary angioplastyPercutaneous coronary intervention (PCI) will be performed by a cardiologist or doctor who specializes in the heart to open coronary arteries that are narrowed or blocked by the buildup of atherosclerotic plaque. PCI requires cardiac catheterization, which is the insertion of a catheter tube, and live x rays helping to guide the catheter into the heart to inject special contrast dye that will highlight the blockage. To open a blocked artery, another catheter will be inserted over a guidewire, a balloon will be inflated at the tip of that catheter, and a small mesh tube called a stent may be put in the artery to help keep the artery open. After PCI, the catheters will be removed, the opening on the wrist or groin will be closed and bandaged. | Procedure or surgery | Control group, Traditional RIC group, Ultrasound-guided-RIC group |
Primary outcome
Infarct size
Time frame: During 0-72 hours after surgery
Cardiac enzyme infarct size is assessed as 72-hour area under the curve (AUC) cardiac troponin T (cTnT) release.
9 secondary outcomes
Plasma concentration of myocardial infarction-related key biomarkers (PCMIKB)
Time frame: Three days after surgery
B-type natriuretic peptide （BNP）
Time frame: Three days after surgery
Left ventricular ejection fraction (LVEF)
Time frame: One week after surgery
Left ventricular end-diastolic volume (LVEDV)
Time frame: One week after surgery
Left ventricular end systolic volume (LVESV).
Time frame: One week after surgery
Cardiopulmonary endurance
Time frame: Three days after surgery
Blood pressure
Time frame: When postoperative RIC is finished（within 10 minutes after PCI）
Heart rate
Time frame: When postoperative RIC is finished（within 10 minutes after PCI）
Total hospital length of stay (LOS)
Time frame: Up to 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
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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.
Xiao Lu, M.D. principal investigator
The First Affiliated Hospital with Nanjing Medical 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 Ultrasound-guided remote ischemic conditioning, Traditional remote ischemic conditioning and Percutaneous coronary intervention in people with Acute Myocardial Infarction, run by The First Affiliated Hospital with Nanjing Medical 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 10 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 11 Nov 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 Yu Zheng, M.D. (+86 17327081766, zhengyu8710@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infarct size (time frame: During 0-72 hours after surgery). 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 11 Nov 2021.