Clinical trial NCT03175952: Virtual Histology Intravascular Ultrasound to Evaluate Prognostic Risks of Saphenous Vein Graft Disease Before Percutaneous Coronary Intervention.
Official title: Virtual Histology Intravascular Ultrasound to Evaluate Prognostic Risks of Saphenous Vein Graft Disease Before Percutaneous Coronary Intervention.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Major Adverse Cardiovascular Events
Saphenous Vein Graft Disease
Virtual Histology Intravascular Ultrasound
Percutaneous Coronary Intervention
Lead sponsor: Tianjin Chest Hospital
Sponsor class: OTHER
First posted: 2017-06-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of major adverse cardiovascular events
timeFrame: after PCI for saphenous vein graft disease (SVGD) in one year
Secondary outcomes:
measure: Thrombolysis In Myocardial Infarction (TIMI) flow in 24 hours after PCI for the SVGD
timeFrame: 24 hours after PCI for the SVGD
measure: 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)
timeFrame: 24 hours after PCI for the SVGD
measure: Success rate of PCI
timeFrame: 24 hours after PCI for the SVGD
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Chest Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Chest Hospital
name: Yin Liu
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.