NCT03175952

Brief Summary

The study is a prospective cohort study conducted in Tianjin Chest Hospital, China. Patients with saphenous vein graft disease after coronary artery bypass graft, and planning for receiving percutaneous coronary intervention after virtual histology intravascular ultrasound will be enrolled between May 2017 and April 2019. These subjects will be followed up at 1, 6 and 12 months post-operation of PCI to assess the short-term and long-term effect.

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
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2017

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

May 1, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 31, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 5, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

September 13, 2017

Status Verified

September 1, 2017

Enrollment Period

2 years

First QC Date

May 31, 2017

Last Update Submit

September 12, 2017

Conditions

Major Adverse Cardiovascular EventsSaphenous Vein Graft DiseaseVirtual Histology Intravascular UltrasoundPercutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (1)

  • Incidence of major adverse cardiovascular events

    Cardiac death, myocardial infarction, target lesion revascularization and target vessel revascularization are all major adverse cardiovascular events

    after PCI for saphenous vein graft disease (SVGD) in one year

Secondary Outcomes (3)

  • Thrombolysis In Myocardial Infarction (TIMI) flow in 24 hours after PCI for the SVGD

    24 hours after PCI for the SVGD

  • Number of slow reflow, no reflow or distal embolization of the saphenous vein graft after PCI on the basis of Corrected TIMI Frame Count (TFC)

    24 hours after PCI for the SVGD

  • Success rate of PCI

    24 hours after PCI for the SVGD

Study Arms (1)

PCI

Diagnostic Test: virtual histology intravascular ultrasound

Interventions

virtual histology intravascular ultrasoundDIAGNOSTIC_TEST

Patients with saphenous vein graft disease will be examined using virtual histology intravascular ultrasound, and treated with percutaneous coronary intervention. Then they will be followed up at 1, 6 and 12 months.

Also known as: percutaneous coronary intervention
PCI

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study is a prospective cohort study conducted in Tianjin Chest Hospital, China. Patients with SVGD after CABG, and planning for receiving PCI after VH-IVUS will be enrolled between April 2017 and March 2019. These subjects will be followed up at 1, 6 and 12 months post-operation of PCI to assess the short-term and long-term effect.

You may qualify if:

  • Patients with SVGD after CABG
  • Planning to receive PCI using drug-eluting stents
  • to 80 years old
  • Finishing VH-IVUS examination
  • Willing to participate in the study and sign informed consent

You may not qualify if:

  • Patients with liver disfunction and renal failure
  • Aspirin and clopidogrel allergy
  • Acute myocardial infarction after CABG
  • History of stroke in the past 3 months
  • Gastrointestinal bleeding and hemoptysis recently
  • Vasculitis and non-atherosclerotic coronary artery disease
  • Coagulation disorders
  • History of malignancy
  • Women during pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Chest Hospital

Tianjin, Tianjin Municipality, 300051, China

RECRUITING

Related Publications (1)

  • Liu Y, Wang HB, Li X, Xiao JY, Wang JX, Reilly KH, Sun B, Gao J. Relationship between plaque composition by virtual histology intravascular ultrasound and clinical outcomes after percutaneous coronary intervention in saphenous vein graft disease patients: study protocol of a prospective cohort study. BMC Cardiovasc Disord. 2018 Dec 12;18(1):233. doi: 10.1186/s12872-018-0975-1.

    PMID: 30541457DERIVED

Study Officials

  • Yin Liu

    Tianjin Chest Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiang Li, Ph.D.

CONTACT

0086-010-82805775-622lixiang_pucri@bjmu.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
director, Cardiology Department

Study Record Dates

First Submitted

May 31, 2017

First Posted

June 5, 2017

Study Start

May 1, 2017

Primary Completion

April 30, 2019

Study Completion

May 1, 2020

Last Updated

September 13, 2017

Record last verified: 2017-09

Locations

CN(1)