Virtual Histology Intravascular Ultrasound to Evaluate Prognostic Risks of Saphenous Vein Graft Disease Before Percutaneous Coronary Intervention.

NCT ID: NCT03175952

Last Updated: 2017-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-01

Study Completion Date

2020-05-01

Brief Summary

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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.

Detailed Description

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Conditions

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Major Adverse Cardiovascular Events Saphenous Vein Graft Disease Virtual Histology Intravascular Ultrasound Percutaneous Coronary Intervention

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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PCI

virtual histology intravascular ultrasound

Intervention Type DIAGNOSTIC_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.

Interventions

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virtual histology intravascular ultrasound

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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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percutaneous coronary intervention

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tianjin Chest Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yin Liu

director, Cardiology Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yin Liu

Role: PRINCIPAL_INVESTIGATOR

Tianjin Chest Hospital

Locations

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Tianjin Chest Hospital

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiang Li, Ph.D.

Role: CONTACT

0086-010-82805775-622

Facility Contacts

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Jing Gao, M.D.

Role: primary

0086-022-88185303

References

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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.

Reference Type DERIVED
PMID: 30541457 (View on PubMed)

Other Identifiers

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16YFZCSY00800

Identifier Type: -

Identifier Source: org_study_id

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