Cardiac SurgeryNICENCT06791551
Non-pharmacologial, Non-invassive Intervention Before Cardiac Surgery: a Randomized Controlled Trial
A study testing active RIPC and tDCS in people with Cardiac Surgery, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
Perioperative neurological complications in cardiovascular surgical procedures are associated with a significant risk of mortality and disability. The goal of this clinical trial is to learn if ischemic preconditioning and transcranial electrical stimulation to reduce perioperative neurological complications. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- active RIPC and tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 10 Jun 2025to 31 Jul 2028
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age range: 18-80 years old;
- Surgical patients with heart disease;
- Elective surgery;
- Patients identified as high-risk for postoperative neurological complications; Previous stroke history; Moderate to severe stenosis of the head and neck arteries was evaluated;
- Be able to understand and comply with the requirements of clinical trial protocols, and voluntarily sign informed consent forms.
Who cannot join
- -
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
Department of Neurology, Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing,
Beijing, Beijing Municipality, 100070
Yao Feng, M.D, 18810643595, fengyao_dr@sina.com
About this study
Official title: Non-pharmacologial, Non-invassive Intervention Before Cardiac Surgry: a Randomized Controlled Trial
Perioperative neurological complications in cardiovascular surgical procedures are associated with a significant risk of mortality and disability. The goal of this clinical trial is to learn if ischemic preconditioning and transcranial electrical stimulation to reduce perioperative neurological complications. It will also learn about the safety of remote ischemic preconditioning and transcranial electrical stimulation before cardiac surgery. The main questions it aims to answer are "Do remote ischemic preconditioning and transcranial electrical stimulation make good effect on perioperative neurological complications?" "Are remote ischemic preconditioning and transcranial electrical stimulation safe?" Researchers will compare remote ischemic preconditioning and transcranial electrical stimulation to traditional treatment to see if remote ischemic preconditioning and transcranial electrical stimulation work to reduce perioperative neurological complications.
Participants will:Undergo remote ischemic preconditioning and transcranial electrical stimulation or sham treatment twice every day for 3 days before surgery.
Undertake psychological assessment and clinical symptom follow-up after cardiac surgery.
- Conditions
- Cardiac Surgery
- Being tested
- active RIPC and tDCS, Sham (No Treatment)
- Keywords
- cardiac surgery, cognitive function, stroke, delirium, non-invasive neuromodulation, Remote Ischemic Preconditioning
- Medical subject headings
- Stroke, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active RIPC and tDCSDevice
Preoperative use of a therapeutic device with sleeves fixed on the upper side of both arms, compressing the bilateral brachial arteries to 200mmHg for 5 minutes, resting for 5 minutes, repeating 5 times, recorded as 1 time, training once in the morning and afternoon each day, and continuing treatment for at least 3 days; Administer transcranial electrical stimulation, 2mA, 30min, for 3 days;
Sham (No Treatment)Device
received sham treatment with the same appearance instrument;
| Study group | Role | What they receive |
|---|---|---|
| active RIPC and tDCS | Active comparator | RIPC and tDCS twice every day for 3 days before cardiac surgery |
| sham RIPC and tDCS | Sham comparator | Sham RIPC and tDCS twice every day for 3 days before cardiac surgery Receives: Device: Sham (No Treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of neurological complications 7 (± 3) days after cardiac surgery
Lethal or non lethal stroke, coma, or motor impairment; Cognitive impairment or delirium
Measured: From enrollment to the post-surgery within 7 (±3) days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start10 Jun 2025 (estimated)
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Shujuan Li, China National Center for Cardiovascular Diseases
- Investigators
- Shujuan Li, M.D., Study director, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06791551
- Sponsor's protocol ID
- 2024-2460-1
- Acronym
- NICE
- Status last verified
- Jun 2025
- First submitted
- 19 Jan 2025
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Goede LL, Oxenford S, Kroneberg D, Meyer GM, Rajamani N, Neudorfer C, Krause P, Lofredi R, Fox MD, Kuhn AA, Horn A. Linking Invasive and Noninvasive Brain Stimulation in Parkinson's Disease: A Randomized Trial. Mov Disord. 2024 Nov;39(11):1971-1981. doi: 10.1002/mds.29940. Epub 2024 Jul 25.
PubMed 39051611Li C, Tao M, Chen D, Wei Q, Xiong X, Zhao W, Tan W, Yang J, Han Y, Zhang H, Zhang S, Liu H, Cao JL. Transcranial Direct Current Stimulation for Anxiety During Laparoscopic Colorectal Cancer Surgery: A Randomized Clinical Trial. JAMA Netw Open. 2024 Apr 1;7(4):e246589. doi: 10.1001/jamanetworkopen.2024.6589.
PubMed 38635271Law YM, Hsu C, Hingorani SR, Richards M, McMullan DM, Jefferies H, Himmelfarb J, Katz R. Randomized controlled trial of remote ischemic preconditioning in children having cardiac surgery. J Cardiothorac Surg. 2024 Jan 3;19(1):5. doi: 10.1186/s13019-023-02450-8.
PubMed 38172875Nyquist P, Georgakis MK. Remote ischemic preconditioning effects on brain vasculature. Neurology. 2019 Jul 2;93(1):15-16. doi: 10.1212/WNL.0000000000007724. Epub 2019 May 29. No abstract available.
PubMed 31142632Hardt JLS, Pohlmann P, Reissfelder C, Rahbari NN. Remote ischemic preconditioning for reduction of ischemia-reperfusion injury after hepatectomy: A randomized sham-controlled trial. Surgery. 2024 Feb;175(2):424-431. doi: 10.1016/j.surg.2023.09.042. Epub 2023 Nov 10.
PubMed 37951812
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-pharmacologial, Non-invassive Intervention Before Cardiac Surgry: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06791551
- Acronym / sponsor ID
- NICE / 2024-2460-1
- Conditions
- Cardiac Surgery
- Keywords
- cardiac surgery, cognitive function, stroke, delirium, non-invasive neuromodulation, Remote Ischemic Preconditioning
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 10 Jun 2025 (estimated)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 24 Jan 2025 (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.
Perioperative neurological complications in cardiovascular surgical procedures are associated with a significant risk of mortality and disability. The goal of this clinical trial is to learn if ischemic preconditioning and transcranial electrical stimulation to reduce perioperative neurological complications. It will also learn about the safety of remote ischemic preconditioning and transcranial electrical stimulation before cardiac surgery. The main questions it aims to answer are "Do remote ischemic preconditioning and transcranial electrical stimulation make good effect on perioperative neurological complications?" "Are remote ischemic preconditioning and transcranial electrical stimulation safe?" Researchers will compare remote ischemic preconditioning and transcranial electrical stimulation to traditional treatment to see if remote ischemic preconditioning and transcranial electrical stimulation work to reduce perioperative neurological complications.
Participants will:Undergo remote ischemic preconditioning and transcranial electrical stimulation or sham treatment twice every day for 3 days before surgery.
Undertake psychological assessment and clinical symptom follow-up after cardiac surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active RIPC and tDCS | Active comparator | –RIPC and tDCS twice every day for 3 days before cardiac surgery |
| sham RIPC and tDCS | Sham comparator | Device: Sham (No Treatment)Sham RIPC and tDCS twice every day for 3 days before cardiac surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age range: 18-80 years old;
- Surgical patients with heart disease;
- Elective surgery;
- Patients identified as high-risk for postoperative neurological complications; Previous stroke history; Moderate to severe stenosis of the head and neck arteries was evaluated;
- Be able to understand and comply with the requirements of clinical trial protocols, and voluntarily sign informed consent forms.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| active RIPC and tDCSPreoperative use of a therapeutic device with sleeves fixed on the upper side of both arms, compressing the bilateral brachial arteries to 200mmHg for 5 minutes, resting for 5 minutes, repeating 5 times, recorded as 1 time, training once in the morning and afternoon each day, and continuing treatment for at least 3 days; Administer transcranial electrical stimulation, 2mA, 30min, for 3 days; | Device | – |
| Sham (No Treatment)received sham treatment with the same appearance instrument; | Device | sham RIPC and tDCS |
Primary outcome
The incidence of neurological complications 7 (± 3) days after cardiac surgery
Time frame: From enrollment to the post-surgery within 7 (±3) days
Lethal or non lethal stroke, coma, or motor impairment; Cognitive impairment or delirium
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 6 Jun 2025.
- Background: PubMed 39051611Goede LL, Oxenford S, Kroneberg D, Meyer GM, Rajamani N, Neudorfer C, Krause P, Lofredi R, Fox MD, Kuhn AA, Horn A. Linking Invasive and Noninvasive Brain Stimulation in Parkinson's Disease: A Randomized Trial. Mov Disord. 2024 Nov;39(11):1971-1981. doi: 10.1002/mds.29940. Epub 2024 Jul 25.
- Background: PubMed 38635271Li C, Tao M, Chen D, Wei Q, Xiong X, Zhao W, Tan W, Yang J, Han Y, Zhang H, Zhang S, Liu H, Cao JL. Transcranial Direct Current Stimulation for Anxiety During Laparoscopic Colorectal Cancer Surgery: A Randomized Clinical Trial. JAMA Netw Open. 2024 Apr 1;7(4):e246589. doi: 10.1001/jamanetworkopen.2024.6589.
- Background: PubMed 38172875Law YM, Hsu C, Hingorani SR, Richards M, McMullan DM, Jefferies H, Himmelfarb J, Katz R. Randomized controlled trial of remote ischemic preconditioning in children having cardiac surgery. J Cardiothorac Surg. 2024 Jan 3;19(1):5. doi: 10.1186/s13019-023-02450-8.
- Background: PubMed 31142632Nyquist P, Georgakis MK. Remote ischemic preconditioning effects on brain vasculature. Neurology. 2019 Jul 2;93(1):15-16. doi: 10.1212/WNL.0000000000007724. Epub 2019 May 29. No abstract available.
- Background: PubMed 37951812Hardt JLS, Pohlmann P, Reissfelder C, Rahbari NN. Remote ischemic preconditioning for reduction of ischemia-reperfusion injury after hepatectomy: A randomized sham-controlled trial. Surgery. 2024 Feb;175(2):424-431. doi: 10.1016/j.surg.2023.09.042. Epub 2023 Nov 10.
- Individual participant dataSharing planned: Undecided
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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.
Shujuan Li, M.D. study director
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 active RIPC and tDCS in people with Cardiac Surgery, run by China National Center for Cardiovascular Diseases 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 1 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 6 Jun 2025. 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. Some participants in this study may receive a placebo. 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 Yao Feng, M.D. (18810643595, fengyao_dr@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of neurological complications 7 (± 3) days after cardiac surgery (time frame: From enrollment to the post-surgery within 7 (±3) days). 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 NCT06791551, which also lists 5 linked publications.
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 6 Jun 2025.