- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03175952
Virtual Histology Intravascular Ultrasound to Evaluate Prognostic Risks of Saphenous Vein Graft Disease Before Percutaneous Coronary Intervention.
September 12, 2017 updated by: Yin Liu, Tianjin Chest Hospital
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
120
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
- Name: Xiang Li, Ph.D.
- Phone Number: 0086-010-82805775-622
- Email: lixiang_pucri@bjmu.edu.cn
Study Locations
-
-
Tianjin
-
Tianjin, Tianjin, China, 300051
- Recruiting
- Tianjin Chest Hospital
-
Contact:
- Jing Gao, M.D.
- Phone Number: 0086-022-88185303
- Email: gaojing2088@163.com
-
-
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
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-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.
Description
Inclusion Criteria:
- Patients with SVGD after CABG
- Planning to receive PCI using drug-eluting stents
- 18 to 80 years old
- Finishing VH-IVUS examination
- Willing to participate in the study and sign informed consent
Exclusion Criteria:
- 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
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
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
PCI
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of major adverse cardiovascular events
Time Frame: after PCI for saphenous vein graft disease (SVGD) in one year
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Thrombolysis In Myocardial Infarction (TIMI) flow in 24 hours after PCI for the SVGD
Time Frame: 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)
Time Frame: 24 hours after PCI for the SVGD
|
24 hours after PCI for the SVGD
|
|
Success rate of PCI
Time Frame: 24 hours after PCI for the SVGD
|
The residual stenosis of SVG is less than 50% and achieving TIMI flow 3
|
24 hours after PCI for the SVGD
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
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 (Actual)
May 1, 2017
Primary Completion (Anticipated)
April 30, 2019
Study Completion (Anticipated)
May 1, 2020
Study Registration Dates
First Submitted
May 31, 2017
First Submitted That Met QC Criteria
June 2, 2017
First Posted (Actual)
June 5, 2017
Study Record Updates
Last Update Posted (Actual)
September 13, 2017
Last Update Submitted That Met QC Criteria
September 12, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- 16YFZCSY00800
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
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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