Coronary Artery DiseaseNCT06841757
The Effect of Remote Ischemic Preconditioning on Diastolic Function in Coronary Artery Bypass Surgery Between Diabetic and Non-Diabetic Patients
A study testing Remote ischemic preconditioning in people with Coronary Artery Disease and Diabetes Mellitus, run by Alzahraa Khalil Marie at 1 site in Egypt.
Trial summary
This randomized controlled study aims to evaluate the effects of Remote Ischemic Preconditioning (RIPC) on diastolic function in patients undergoing coronary artery bypass grafting (CABG). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Diabetes Mellitus, Diastolic Function
- What is being tested?
- Remote ischemic preconditioning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to Jul 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult patients scheduled for elective isolated on-pump CABG surgery for two- to three-vessel coronary artery disease.
- Both males and females will be included.
- In the diabetic groups: Type II diabetes currently requiring and adhering to insulin therapy for at least the past 3 months
- During cardiopulmonary bypass, the temperature will range from 28-33°C using an esophageal temperature probe.
- Antegrade warm cardioplegia will be given by the cardiovascular perfusionist.
- Baseline diastolic function will be obtained preoperatively using transthoracic echocardiography done within the six months prior to the surgery
Who cannot join
- Combined CABG and valve surgery, emergency CABG.
- Type I diabetes, Type 2 diabetes managed with oral hypoglycemic agents without insulin in the past 3 months
- Peripheral vascular disease (PVD) affecting the upper limbs.
- Acute coronary syndrome (ACS); acute or recent myocardial infarction.
- Left ventricular ejection fraction ≤30%.
- Serious pulmonary disease necessitating oxygen supplementation or mechanical ventilation.
- Renal failure, defined as eGFR < 30 mL/min/1.73 m² or requiring renal replacement therapy (dialysis).
- Liver failure, including Child-Pugh Class B or C cirrhosis, severe hepatocellular dysfunction, or listed for liver transplantation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Remote Ischemic Preconditioning on Diastolic Function in Coronary Artery Bypass Surgery: A Randomized Controlled Study Comparing Diabetic and Non-Diabetic Patients
This randomized controlled study aims to evaluate the effects of Remote Ischemic Preconditioning (RIPC) on diastolic function in patients undergoing coronary artery bypass grafting (CABG). The study will compare diabetic and non-diabetic patients to determine whether RIPC improves myocardial relaxation and reduces diastolic dysfunction, as assessed by the E/e' ratio at multiple time points during the surgery.
- Being tested
- Remote ischemic preconditioning
- Keywords
- Coronary artery bypass surgery, Diastolic function, Remote ischemic preconditioning
- Medical subject headings
- Coronary Artery Disease, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischemic preconditioningBehavioural
Patients will undergo Remote Ischemic Preconditioning using a blood pressure cuff inflated on the upper limb to induce ischemia and reperfusion, 40 mmHg above systolic pressure. The procedure will involve 3 cycles of inflation (5 minutes each) and deflation (5 minutes each) post intubation
| Study group | Role | What they receive |
|---|---|---|
| Diabetic with Remote ischemic preconditioning | Experimental | Remote Ischemic Preconditioning (RIPC) Patients will undergo Remote Ischemic Preconditioning using a blood pressure cuff inflated on the upper limb to induce ischemia and reperfusion, 40 mmHg above systolic pressure. The procedure will involve 3 cycles of inflation (5 minutes each) and deflation (5 minutes each) post intubation. Receives: Behavioral: Remote ischemic preconditioning |
| Non diabetic with Remote ischemic preconditioning | Experimental | Remote Ischemic Preconditioning (RIPC) Non-diabetic patients who undergo Remote ischemic preconditioning using the same ischemia/reperfusion protocol as the diabetic group. Receives: Behavioral: Remote ischemic preconditioning |
| Diabetic without Remote ischemic preconditioning | No intervention | Diabetic patients who receive standard care for CABG surgery without Remote ischemic preconditioning |
| Non diabetic without Remote ischemic preconditioning | No intervention | Non-diabetic patients who receive standard care for CABG surgery without RIPC. |
What is being measured
The primary outcome is the main question the study is designed to answer.
E/e' Ratio (Diastolic Function)
Echocardiography (Tissue Doppler Imaging) will be used to measure the E/e' ratio, a reliable parameter for assessing left ventricular filling pressure and diastolic function. This is the primary method to evaluate the effect of Remote Ischemic Preconditioning (RIPC) on diastolic function in both diabetic and non-diabetic patients undergoing CABG.
Measured: T1: immediately after anesthesia induction and intubation (baseline) T2: Immediately before cardiopulmonary bypass (CPB) T3: 10 minutes after reperfusion and separation from CPB T4: 45 minutes after separation from CPB and before transfer to the ICU
Secondary outcomes (6)
Mitral Inflow Velocities(E/A Ratio)
Using TEE to measure E/A ratio
Measured: T1: immediately after anesthesia induction and intubation (baseline) T2: Immediately before cardiopulmonary bypass (CPB) T3: 10 minutes after reperfusion and separation from CPB T4: 45 minutes after separation from CPB and before transfer to the ICU
Deceleration Time (DT)
Measured: T1: immediately after anesthesia induction and intubation (baseline) T2: Immediately before cardiopulmonary bypass (CPB) T3: 10 minutes after reperfusion and separation from CPB T4: 45 minutes after separation from CPB and before transfer to the ICU
Cardiac Troponin Levels
Measured: Evaluate cardiac troponin levels postoperatively after 24 hours as a marker of myocardial injury
Systolic and diastolic Blood pressure
Measured: T1: immediately after anesthesia induction and intubation (baseline) T2: Immediately before cardiopulmonary bypass (CPB) T3: 10 minutes after reperfusion and separation from CPB T4: 45 minutes after separation from CPB and before transfer to the ICU
Inotropic Support:
Usage and dose.
Measured: During surgery
LVEF
Ejection fraction
Measured: Compare between start and end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start1 Jan 2025
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (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 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alzahraa Khalil Marie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alzahraa Khalil Marie, Cairo University
- Investigators
- Ahmed Alagaty Ehsan Alagaty, Professor of anesthesia, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06841757
- Sponsor's protocol ID
- MD-342-2024
- Status last verified
- Oct 2024
- First submitted
- 13 Feb 2025
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Roth GA, Mensah GA, Johnson CO, Addolorato G, Ammirati E, Baddour LM, Barengo NC, Beaton AZ, Benjamin EJ, Benziger CP, Bonny A, Brauer M, Brodmann M, Cahill TJ, Carapetis J, Catapano AL, Chugh SS, Cooper LT, Coresh J, Criqui M, DeCleene N, Eagle KA, Emmons-Bell S, Feigin VL, Fernandez-Sola J, Fowkes G, Gakidou E, Grundy SM, He FJ, Howard G, Hu F, Inker L, Karthikeyan G, Kassebaum N, Koroshetz W, Lavie C, Lloyd-Jones D, Lu HS, Mirijello A, Temesgen AM, Mokdad A, Moran AE, Muntner P, Narula J, Neal B, Ntsekhe M, Moraes de Oliveira G, Otto C, Owolabi M, Pratt M, Rajagopalan S, Reitsma M, Ribeiro ALP, Rigotti N, Rodgers A, Sable C, Shakil S, Sliwa-Hahnle K, Stark B, Sundstrom J, Timpel P, Tleyjeh IM, Valgimigli M, Vos T, Whelton PK, Yacoub M, Zuhlke L, Murray C, Fuster V; GBD-NHLBI-JACC Global Burden of Cardiovascular Diseases Writing Group. Global Burden of Cardiovascular Diseases and Risk Factors, 1990-2019: Update From the GBD 2019 Study. J Am Coll Cardiol. 2020 Dec 22;76(25):2982-3021. doi: 10.1016/j.jacc.2020.11.010.
PubMed 33309175
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Remote Ischemic Preconditioning on Diastolic Function in Coronary Artery Bypass Surgery: A Randomized Controlled Study Comparing Diabetic and Non-Diabetic Patients
- ClinicalTrials.gov ID
- NCT06841757
- Acronym / sponsor ID
- MD-342-2024
- Keywords
- Coronary artery bypass surgery, Diastolic function, Remote ischemic preconditioning
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Alzahraa Khalil MarieUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 24 Feb 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.
This randomized controlled study aims to evaluate the effects of Remote Ischemic Preconditioning (RIPC) on diastolic function in patients undergoing coronary artery bypass grafting (CABG). The study will compare diabetic and non-diabetic patients to determine whether RIPC improves myocardial relaxation and reduces diastolic dysfunction, as assessed by the E/e' ratio at multiple time points during the surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Diabetic with Remote ischemic preconditioning | Experimental | Behavioral: Remote ischemic preconditioningRemote Ischemic Preconditioning (RIPC) Patients will undergo Remote Ischemic Preconditioning using a blood pressure cuff inflated on the upper limb to induce ischemia and reperfusion, 40 mmHg above systolic pressure. The procedure will involve 3 cycles of inflation (5 minutes each) and deflation (5 minutes each) post intubation. |
| Non diabetic with Remote ischemic preconditioning | Experimental | Behavioral: Remote ischemic preconditioningRemote Ischemic Preconditioning (RIPC) Non-diabetic patients who undergo Remote ischemic preconditioning using the same ischemia/reperfusion protocol as the diabetic group. |
| Diabetic without Remote ischemic preconditioning | No intervention | –Diabetic patients who receive standard care for CABG surgery without Remote ischemic preconditioning |
| Non diabetic without Remote ischemic preconditioning | No intervention | –Non-diabetic patients who receive standard care for CABG surgery without RIPC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- All adult patients scheduled for elective isolated on-pump CABG surgery for two- to three-vessel coronary artery disease.
- Both males and females will be included.
- In the diabetic groups: Type II diabetes currently requiring and adhering to insulin therapy for at least the past 3 months
- During cardiopulmonary bypass, the temperature will range from 28-33°C using an esophageal temperature probe.
- Antegrade warm cardioplegia will be given by the cardiovascular perfusionist.
Key exclusion criteria (8 listed)
- Combined CABG and valve surgery, emergency CABG.
- Type I diabetes, Type 2 diabetes managed with oral hypoglycemic agents without insulin in the past 3 months
- Peripheral vascular disease (PVD) affecting the upper limbs.
- Acute coronary syndrome (ACS); acute or recent myocardial infarction.
- Left ventricular ejection fraction ≤30%.
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 preconditioningPatients will undergo Remote Ischemic Preconditioning using a blood pressure cuff inflated on the upper limb to induce ischemia and reperfusion, 40 mmHg above systolic pressure. The procedure will involve 3 cycles of inflation (5 minutes each) and deflation (5 minutes each) post intubation | Behavioural | Diabetic with Remote ischemic preconditioning, Non diabetic with Remote ischemic preconditioning |
Primary outcome
E/e' Ratio (Diastolic Function)
Time frame: T1: immediately after anesthesia induction and intubation (baseline) T2: Immediately before cardiopulmonary bypass (CPB) T3: 10 minutes after reperfusion and separation from CPB T4: 45 minutes after separation from CPB and before transfer to the ICU
Echocardiography (Tissue Doppler Imaging) will be used to measure the E/e' ratio, a reliable parameter for assessing left ventricular filling pressure and diastolic function. This is the primary method to evaluate the effect of Remote Ischemic Preconditioning (RIPC) on diastolic function in both diabetic and non-diabetic patients undergoing CABG.
6 secondary outcomes
Mitral Inflow Velocities(E/A Ratio)
Time frame: T1: immediately after anesthesia induction and intubation (baseline) T2: Immediately before cardiopulmonary bypass (CPB) T3: 10 minutes after reperfusion and separation from CPB T4: 45 minutes after separation from CPB and before transfer to the ICU
Deceleration Time (DT)
Time frame: T1: immediately after anesthesia induction and intubation (baseline) T2: Immediately before cardiopulmonary bypass (CPB) T3: 10 minutes after reperfusion and separation from CPB T4: 45 minutes after separation from CPB and before transfer to the ICU
Cardiac Troponin Levels
Time frame: Evaluate cardiac troponin levels postoperatively after 24 hours as a marker of myocardial injury
Systolic and diastolic Blood pressure
Time frame: T1: immediately after anesthesia induction and intubation (baseline) T2: Immediately before cardiopulmonary bypass (CPB) T3: 10 minutes after reperfusion and separation from CPB T4: 45 minutes after separation from CPB and before transfer to the ICU
Inotropic Support:
Time frame: During surgery
LVEF
Time frame: Compare between start and end of surgery
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 24 Feb 2025.
- Background: PubMed 33309175Roth GA, Mensah GA, Johnson CO, Addolorato G, Ammirati E, Baddour LM, Barengo NC, Beaton AZ, Benjamin EJ, Benziger CP, Bonny A, Brauer M, Brodmann M, Cahill TJ, Carapetis J, Catapano AL, Chugh SS, Cooper LT, Coresh J, Criqui M, DeCleene N, Eagle KA, Emmons-Bell S, Feigin VL, Fernandez-Sola J, Fowkes G, Gakidou E, Grundy SM, He FJ, Howard G, Hu F, Inker L, Karthikeyan G, Kassebaum N, Koroshetz W, Lavie C, Lloyd-Jones D, Lu HS, Mirijello A, Temesgen AM, Mokdad A, Moran AE, Muntner P, Narula J, Neal B, Ntsekhe M, Moraes de Oliveira G, Otto C, Owolabi M, Pratt M, Rajagopalan S, Reitsma M, Ribeiro ALP, Rigotti N, Rodgers A, Sable C, Shakil S, Sliwa-Hahnle K, Stark B, Sundstrom J, Timpel P, Tleyjeh IM, Valgimigli M, Vos T, Whelton PK, Yacoub M, Zuhlke L, Murray C, Fuster V; GBD-NHLBI-JACC Global Burden of Cardiovascular Diseases Writing Group. Global Burden of Cardiovascular Diseases and Risk Factors, 1990-2019: Update From the GBD 2019 Study. J Am Coll Cardiol. 2020 Dec 22;76(25):2982-3021. doi: 10.1016/j.jacc.2020.11.010.
- Individual participant dataSharing planned: No
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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.
Ahmed Alagaty Ehsan Alagaty, Professor of anesthesia principal investigator
Cairo 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 preconditioning in people with Coronary Artery Disease and Diabetes Mellitus, run by Alzahraa Khalil Marie at 1 site in Egypt.
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 6 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: under way, not looking for participants, as of the sponsor's last update on 24 Feb 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 Egypt. 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?
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?
E/e' Ratio (Diastolic Function) (time frame: T1: immediately after anesthesia induction and intubation (baseline) T2: Immediately before cardiopulmonary bypass (CPB) T3: 10 minutes after reperfusion and separation from CPB T4: 45 minutes after separation from CPB and before transfer to the ICU). 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 NCT06841757, 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 24 Feb 2025.