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NCT Number: NCT06728605

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

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.

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Key information

Conditions

Coronary Heart Disease (CHD) Cardio-pulmonary Bypass Cardiogenic Shock Acute Cardiovascular Diseases Congestive Heart Failure Chronic Coronary Disease Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Shock, Cardiogenic Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.
  • Pregnancy.

Treatment and study plan

Enhanced External Counterpulsation (EECP)

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%.

Sham Comparator

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%.

Primary outcomes

  1. SOFA score

    Time frame: within the prior 7 days after cardiac surgery.

Study contacts

Contact information is provided by the study sponsor or research team.

Hong Liu, MD

CONTACT

[email protected]

18801281613

Yong-feng Shao, MD

CONTACT

[email protected]

02568303101

Sponsors and collaborators

Lead sponsor

Nanjing Medical University

Other

Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

Registry information

Official study title

Protective Effect of Enhanced External Counterpulsation Against Negative Inflammatory Response and Organ Dysfunction After Cardiovascular Surgery

Acronym: PANDA

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 11, 2024
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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