NCT03766529

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

December 3, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 6, 2018

Completed
Last Updated

December 7, 2018

Status Verified

December 1, 2018

Enrollment Period

2.9 years

First QC Date

December 3, 2018

Last Update Submit

December 5, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Concentration of postoperative maximum cardiac troponin T

    postoperative maximum concentration serum cardiac troponin T (cTnT) as markers of myocardial injury.

    up to 30 days

Interventions

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.

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TEDA International Cardiovascular Hospital

Tianjin, Tianjin Municipality, 300457, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Investigator

Study Record Dates

First Submitted

December 3, 2018

First Posted

December 6, 2018

Study Start

January 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

December 7, 2018

Record last verified: 2018-12

Locations