Protective Effect of EECP Against Negative Inflammatory Response and Organ Dysfunction After Cardiovascular Surgery

NCT ID: NCT06728605

Last Updated: 2024-12-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2025-12-31

Brief Summary

Enhanced external counterpulsation (EECP) is a noninvasive, non-pharmacologic intervention proven to increase nitric oxide bioavailability in patients with coronary artery disease. Although EECP showed short-term effects in improving coronary flow in patients with coronary slow flow, whether such improvement is durable remains uncertain, and the relationships between such improvement and changes in multiple organ functions as well as inflammatory markers have not been elucidated. The purpose of this study will be to evaluate the potential clinical benefits of EECP on organ function and proinflammatory cytokine concentrations during post-acute sequela of cardiovascular surgery.

Conditions

Coronary Heart Disease (CHD); Cardio-pulmonary Bypass; Congestive Heart Failure Chronic; Cardiogenic Shock Acute

Keywords

cardiac surgery; cardiopulmonary bypass; cardiogenic shock

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

EECP group

Patients randomly assigned to EECP received 3 half-h sessions of EECP for 3 days before surgery. Three pneumatic cuffs will be placed around the lower limbs and buttocks and will be inflated sequentially upward at the onset of diastole, and released rapidly and simultaneously before the onset of systole. The protocol-specified applied pressure will be 300 mm Hg and will be reached within 5 min of the initiation of treatment. Pulse oximetry will be monitored continuously during the treatment session, and the subject's clinical status will be re-evaluated if the oxygen saturation dropps by 4%.

Group Type: EXPERIMENTAL

Enhanced External Counterpulsation (EECP)

Intervention Type: DEVICE

Patients randomly assigned to EECP received 3 1/2-h sessions of EECP for 3 days before surgery. Three pneumatic cuffs will be placed around the lower limbs and buttocks and will be inflated sequentially upward at the onset of diastole, and released rapidly and simultaneously before the onset of systole. The protocol-specified applied pressure will be 300 mm Hg and was reached within 5 min of the initiation of treatment. Pulse oximetry will be monitored continuously during the treatment session, and the subject's clinical status will be re-evaluated if the oxygen saturation drops by 4%.

Control group

Patients randomly assigned to control received 3 half-h sessions of sham for 3 days before surgery. Three pneumatic cuffs will be placed around the lower limbs and buttocks and will be inflated sequentially upward at the onset of diastole, and released rapidly and simultaneously before the onset of systole. The protocol-specified applied pressure will be 70 mm Hg and will be reached within 5 min of the initiation of treatment. Pulse oximetry will be monitored continuously during the treatment session, and the subject's clinical status will be re-evaluated if the oxygen saturation dropps by 4%.

Group Type: SHAM_COMPARATOR

Sham Comparator

Intervention Type: DEVICE

Patients randomly assigned to sham group received 3 1/2-h sessions of sham treatment for 3 days before surgery. Three pneumatic cuffs will be placed around the lower limbs and buttocks and will be inflated sequentially upward at the onset of diastole, and released rapidly and simultaneously before the onset of systole. The protocol-specified applied pressure will be 70 mm Hg and was reached within 5 min of the initiation of treatment. Pulse oximetry will be monitored continuously during the treatment session, and the subject's clinical status will be re-evaluated if the oxygen saturation drops by 4%.

Interventions

Enhanced External Counterpulsation (EECP)

Patients randomly assigned to EECP received 3 1/2-h sessions of EECP for 3 days before surgery. Three pneumatic cuffs will be placed around the lower limbs and buttocks and will be inflated sequentially upward at the onset of diastole, and released rapidly and simultaneously before the onset of systole. The protocol-specified applied pressure will be 300 mm Hg and was reached within 5 min of the initiation of treatment. Pulse oximetry will be monitored continuously during the treatment session, and the subject's clinical status will be re-evaluated if the oxygen saturation drops by 4%.

Intervention Type: DEVICE

Sham Comparator

Patients randomly assigned to sham group received 3 1/2-h sessions of sham treatment for 3 days before surgery. Three pneumatic cuffs will be placed around the lower limbs and buttocks and will be inflated sequentially upward at the onset of diastole, and released rapidly and simultaneously before the onset of systole. The protocol-specified applied pressure will be 70 mm Hg and was reached within 5 min of the initiation of treatment. Pulse oximetry will be monitored continuously during the treatment session, and the subject's clinical status will be re-evaluated if the oxygen saturation drops by 4%.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age > 18 years;
• Patients with Stable angina pectoris, unstable angina pectoris, acute myocardial infarction, congestive heart failure, cardiogenic shock;
• Patients chronic heart failure;
• Patients are ready to received cardiovascular surgery during this hospital admission.
• Patients agree to participate in the study and sign an informed consent form.

Exclusion Criteria

1. Moderate to severe aortic insufficiency; 2. Dissection aneurysm; 3. Significant pulmonary hypertension; 4, A variety of bleeding diseases or bleeding tendencies, or use anticoagulants, INR>2.0; 5, active phlebitis, venous thrombosis; 6. There is an infection in the counterpulsating limb; 7. Uncontrolled hyperhypertension (>170/110mmHg); 8. Uncontrolled arrhythmias: frequent premature beats, rapid atrial fibrillation, etc.

9. Pregnancy.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: collaborator

Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Hong Liu

Principal Investigator of Department of Cardiovascular Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jun-jie Du, MD

Role: STUDY_DIRECTOR

The First Affiliated Hospital with Nanjing Medical University

Locations

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Countries

China

Central Contacts

Hong Liu, MD

Role: CONTACT

Phone: 18801281613

Email: dr.hongliu@foxmail.com

Yong-feng Shao, MD

Role: CONTACT

Phone: 02568303101

Email: yfshaojph@sina.com

Facility Contacts

Hong Liu, MD

Role: primary

Yong-feng Shao, MD

Role: backup

Jun-jie Du, MD

Role: backup

References

Masuda D, Nohara R, Hirai T, Kataoka K, Chen LG, Hosokawa R, Inubushi M, Tadamura E, Fujita M, Sasayama S. Enhanced external counterpulsation improved myocardial perfusion and coronary flow reserve in patients with chronic stable angina; evaluation by(13)N-ammonia positron emission tomography. Eur Heart J. 2001 Aug;22(16):1451-8. doi: 10.1053/euhj.2000.2545.

Reference Type: BACKGROUND

PMID: 11482918 (View on PubMed)

Kiernan TJ, Boilson BA, Tesmer L, Harbuzariu A, Simari RD, Barsness GW. Effect of enhanced external counterpulsation on circulating CD34+ progenitor cell subsets. Int J Cardiol. 2011 Dec 1;153(2):202-6. doi: 10.1016/j.ijcard.2010.08.020. Epub 2010 Sep 16.

Reference Type: BACKGROUND

PMID: 20843569 (View on PubMed)

Sardina PD, Martin JS, Dzieza WK, Braith RW. Enhanced external counterpulsation (EECP) decreases advanced glycation end products and proinflammatory cytokines in patients with non-insulin-dependent type II diabetes mellitus for up to 6 months following treatment. Acta Diabetol. 2016 Oct;53(5):753-60. doi: 10.1007/s00592-016-0869-6. Epub 2016 Jun 9.

Reference Type: BACKGROUND

PMID: 27278477 (View on PubMed)

Other Identifiers

PANDA IX

Identifier Type: -

Identifier Source: org_study_id