- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00982852
Intravascular Ultrasound Derived Virtual Histology and Intracoronary Serum Markers of Inflammation
Intravascular Ultrasound Derived Virtual Histology and Intracoronary Serum Markers of Inflammation in Patients Referred for Percutaneous Coronary Intervention.
Patients enrolled will need treated with an IVUS- VH (intravascular ultrasound-derived virtual histology) which is an arterial stent procedure, that involves threading a tiny wire into the artery, followed by a balloon, a stent, or other device to treat a blocked artery, and often (though not always), a special ultrasound catheter to take pictures of the inside of the artery.
Participants in the study, will have an additional procedure performed: a tiny tube will be advanced into the heart artery to collect a blood sample for research purposes, and a blood sample will be collected from the femoral (thigh) artery through the tube that will be placed there as a standard part of having this procedure.
The blood that is collected will be analyzed for markers of inflammation or irritation in the blood (c-reactive protein, myeloperoxidase, Monocyte chemotactic protein-1), as well and a gene called Matrix Metallopeptidase 3, which is believe to influence the progression of plaque on the walls of arteries and the progression of coronary artery disease. .
Study Overview
Status
Detailed Description
Patients that have severe blockage in one of the arteries that provides blood flow to your heart will be enrolled into the research study. Most of the procedures in the study standard care used by cardiologists when treating blocked arteries. Patients enrolled will need treated with an IVUS- VH (intravascular ultrasound-derived virtual histology) which is an arterial stent procedure, that involves threading a tiny wire into the artery, followed by a balloon, a stent, or other device to treat a blocked artery, and often (though not always), a special ultrasound catheter to take pictures of the inside of the artery. We will collect all the data from the above stated standard medical care procedure.
Participants in the study, will have an additional procedure performed: a tiny tube will be advanced into the heart artery to collect a blood sample for research purposes, and a blood sample will be collected from the femoral (thigh) artery through the tube that will be placed there as a standard part of having this procedure.
The blood that is collected will be analyzed for markers of inflammation or irritation in the blood (c-reactive protein, myeloperoxidase, Monocyte chemotactic protein-1), as well and a gene called Matrix Metallopeptidase 3, which is believe to influence the progression of plaque on the walls of arteries and the progression of coronary artery disease. .
Finally, after discharged from the hospital, the research nurses will call you at home to ask you questions about how you are doing for approximately 5-10 minutes. Telephone follow-up will occur at one month, six months, 12 months, 18 months, 24 months, and 36 months.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Ohio
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Columbus, Ohio, United States, 43210
- The Ohio State University Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- In- or out-patients admitted to IPR or hospital floor for left heart catheterization or scheduled angioplasty
- 18 years or older
- Able to provide informed consent
Exclusion Criteria:
- Patients who are pregnant or lactating
- Inability to provide informed consent
- Patients undergoing heart catheterization for who open heart surgery is planned
- Anticipate being unavailable for telephone follow-up
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Acute
Patients in acute need for angioplasty or left heart catheterization.
|
Chronic or non-acute
Patients will planned angioplasty or left heart catheterization.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Occurrence or absence of adverse cardiovascular outcomes up to 36 months after PCI
Time Frame: 36 months
|
36 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Quinn Capers IV, MD, Ohio State University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2008H0112
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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