Major Adverse Cardiovascular EventsNCT03175952
Virtual Histology Intravascular Ultrasound to Evaluate Prognostic Risks of Saphenous Vein Graft Disease Before Percutaneous Coronary Intervention.
An observational study of Major Adverse Cardiovascular Events and Saphenous Vein Graft Disease, run by Tianjin Chest Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Major Adverse Cardiovascular Events, Saphenous Vein Graft Disease, Virtual Histology Intravascular Ultrasound
- What is being tested?
- virtual histology intravascular ultrasound
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2017to 1 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Coagulation disorders
- History of malignancy
- Women during pregnancy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, 300051
Jing Gao, M.D., 0086-022-88185303, gaojing2088@163.com
About this study
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.
- Conditions
- Major Adverse Cardiovascular Events, Saphenous Vein Graft Disease, Virtual Histology Intravascular Ultrasound, Percutaneous Coronary Intervention
- Being tested
- virtual histology intravascular ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual histology intravascular ultrasoundDiagnostic test
Also called percutaneous coronary intervention
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.
| Study group | Role | What they receive |
|---|---|---|
| PCI | Not described Receives: Diagnostic Test: virtual histology intravascular ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of major adverse cardiovascular events
Cardiac death, myocardial infarction, target lesion revascularization and target vessel revascularization are all major adverse cardiovascular events
Measured: 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
Measured: 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)
Measured: 24 hours after PCI for the SVGD
Success rate of PCI
The residual stenosis of SVG is less than 50% and achieving TIMI flow 3
Measured: 24 hours after PCI for the SVGD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start1 May 2017
- Primary completion30 Apr 2019 (estimated)
- Study completion1 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Adverse Cardiovascular EventsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yin Liu, Tianjin Chest Hospital
- Investigators
- Yin Liu, Principal investigator, Tianjin Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03175952
- Sponsor's protocol ID
- 16YFZCSY00800
- Status last verified
- Sep 2017
- First submitted
- 31 May 2017
- Last updated
- 13 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30541457
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Histology Intravascular Ultrasound to Evaluate Prognostic Risks of Saphenous Vein Graft Disease Before Percutaneous Coronary Intervention.
- ClinicalTrials.gov ID
- NCT03175952
- Acronym / sponsor ID
- 16YFZCSY00800
- Conditions
- Major Adverse Cardiovascular Events, Saphenous Vein Graft Disease, Virtual Histology Intravascular Ultrasound, Percutaneous Coronary Intervention
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Tianjin Chest HospitalUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 30 Apr 2019 (estimated)
- Study completion
- 1 May 2020 (estimated)
- First posted
- 5 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PCI | – | Diagnostic Test: virtual histology intravascular ultrasound |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| virtual histology intravascular ultrasoundAlso: percutaneous coronary interventionPatients 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. | Diagnostic test | PCI |
Primary outcome
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
3 secondary outcomes
Thrombolysis In Myocardial Infarction (TIMI) flow in 24 hours after PCI for the SVGD
Time frame: 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
Success rate of PCI
Time frame: 24 hours after PCI for the SVGD
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2017.
- Derived from this study: PubMed 30541457Liu 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yin Liu principal investigator
Tianjin Chest Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Adverse Cardiovascular Events and Saphenous Vein Graft Disease, run by Tianjin Chest Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiang Li, Ph.D. (0086-010-82805775-622, lixiang_pucri@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of major adverse cardiovascular events (time frame: after PCI for saphenous vein graft disease (SVGD) in one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03175952, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2017.