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

December 10, 2024 updated by: Hong Liu, Nanjing Medical University

Protective Effect of Enhanced External Counterpulsation 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • The First Affiliated Hospital of Nanjing Medical University
        • Contact:
        • Contact:
        • Contact:
          • Jun-jie Du, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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%.
Device: 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%.
Sham Comparator: 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%.
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%.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
SOFA score
Time Frame: within the prior 7 days after cardiac surgery.
within the prior 7 days after cardiac surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing Medical University

Collaborators

The First Affiliated Hospital with Nanjing Medical University

Investigators

  • Study Director: Jun-jie Du, MD, The First Affiliated Hospital with Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 31, 2025

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

December 6, 2024

First Submitted That Met QC Criteria

December 10, 2024

First Posted (Estimated)

December 11, 2024

Study Record Updates

Last Update Posted (Estimated)

December 11, 2024

Last Update Submitted That Met QC Criteria

December 10, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PANDA IX

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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