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Loop Isolation-based Uploading Pre-conditioning

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ClinicalTrials.gov Identifier: NCT03766529
Recruitment Status : Unknown
Verified December 2018 by Hong Liu, Nanjing Medical University.
Recruitment status was:  Recruiting
First Posted : December 6, 2018
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
Hong Liu, Nanjing Medical University

Study Description
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Brief 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).

Condition or disease Intervention/treatment
Ischaemic Heart Diseases Procedure: loop isolation-based uploading preconditioning (LiuPhD)

Detailed 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.
Study Design
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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Loop Isolation-based Uploading Pre-conditioning to Protect Heart From Ischemic-Reperfusion Damage in Coronary Artery Bypass Surgery
Actual Study Start Date : January 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018
Groups and Cohorts
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Intervention Details:
  • 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.

Outcome Measures
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Primary Outcome Measures :
  1. Concentration of postoperative maximum cardiac troponin T [ Time Frame: up to 30 days ]
    postoperative maximum concentration serum cardiac troponin T (cTnT) as markers of myocardial injury.


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The LiuPhD (Loop Isolation-based Uploading Preconditioning to Protect Heart from ischemic-reperfusion Damage) study was a prospective, open-label, single-arm, first-in-man trial on the use of LiuPhD strategy for myocardial protection in patients who underwent surgical coronary revascularization.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03766529


Contacts
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Contact: Hong Liu, MD 8618801281613 dr.hongliu@foxmail.com

Locations
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China, Tianjin
TEDA International Cardiovascular Hospital Recruiting
Tianjin, Tianjin, China, 300457
Contact: Hong Liu, MD    188012181613    dr.hongliu@foxmail.com   
Sponsors and Collaborators
Nanjing Medical University
More Information
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Responsible Party: Hong Liu, Clinical Investigator, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT03766529    
Other Study ID Numbers: LiuPhD
First Posted: December 6, 2018    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Cardiovascular Diseases
 Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases