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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03766529
Other study ID # LiuPhD
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 2016
Est. completion date December 2018

Study information

Verified date December 2018
Source Nanjing Medical University
Contact Hong Liu, MD
Phone 8618801281613
Email dr.hongliu@foxmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Myocardial protection is of crucial importance for surgical coronary revascularization in patients with ischaemic heart diseases. The investigators proposed loop isolation-based uploading preconditioning to protect heart from ischemic-reperfusion damage (LiuPhD) as a novel cardioprotective strategy, and applied to patients who underwent on-pump coronary artery bypass grafting (CABG).


Description:

Myocardial protection is of crucial importance for surgical coronary revascularization in patients with ischaemic heart diseases. Considerable effort has been made to optimize cardioprotective strategy for improving cardiac performances after global myocardial ischemia. Of various strategies, terminal warm blood cardioplegia (TWBC) delivery has been proven to be effective in reducing risk of ischemic attack at the time of myocardial reperfusion. Based on TWBC strategy and Frank-Starling law of heart, the investigators proposed loop isolation-based uploading preconditioning to protect heart from ischemic-reperfusion damage (LiuPhD) as a novel myocardial protective strategy, which procedurally renders coronary loop via brief warm blood delivery independent of extracorporeal loop following TWBC delivery just before declamping. The investigators hypothesize that LiuPhD strategy allows myocardial cells complete depolarization and drives heart into zero-loading heat cycles, contributing to enhancing myocardial physiologic reserve and improving cardiac initiative capacity responding to upcoming loading increases after onset of clamp release. The aim of the present study was to determine whether LiuPhD strategy during on-pump coronary artery bypass grafting (CABG) can attenuate reperfusion injury after global myocardial ischemia.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 2018
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender All
Age group 50 Years to 90 Years
Eligibility Inclusion Criteria:

- Patients scheduled for a first, elective, isolated, open thoracotomy, on-pump CABG were eligible for enrollment if they if they had coronary angiography-confirmed unprotected left main disease, 3-vessel disease with or without proximal LAD artery disease, or 2-vessel disease with proximal LAD artery disease.

- Inclusion criteria were evidence of preserved left ventricular function (LVEF=35%) and normal or mild pulmonary hypertension (sPAP<50mmHg).

Exclusion Criteria:

- Exclusion criteria were secondary CABG, emergency CABG, conversion operations form off-pump CABG or minimally invasive CABG surgery, or any additional cardiac lesions necessitating concomitant surgery, as well as being considered too high risk for surgical revascularization.

Study Design


Intervention

Procedure:
loop isolation-based uploading preconditioning (LiuPhD)
declamping was not done until heart could resume normal mechanical activities and sustain well for three minutes in terms of heart rate, rhythm, and myocardial contractility via continuous antegrade warm blood delivery closely following TWBC reperfusion.

Locations

Country Name City State
China TEDA International Cardiovascular Hospital Tianjin Tianjin

Sponsors (1)

Lead Sponsor Collaborator
Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Concentration of postoperative maximum cardiac troponin T postoperative maximum concentration serum cardiac troponin T (cTnT) as markers of myocardial injury. up to 30 days
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Completed NCT00789451 - The Effect of Ischaemic-reperfusion on the Endogenous Fibrinolysis in Man N/A