Intravascular Ultrasound Derived Virtual Histology and Intracoronary Serum Markers of Inflammation
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Purpose
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. .
| Condition |
|---|
|
Coronary Artery Disease Atherosclerosis Myocardial Infarction Heart Failure Angina |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Intravascular Ultrasound Derived Virtual Histology and Intracoronary Serum Markers of Inflammation in Patients Referred for Percutaneous Coronary Intervention. |
- Occurrence or absence of adverse cardiovascular outcomes up to 36 months after PCI [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
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.
| Estimated Enrollment: | 250 |
| Study Start Date: | December 2008 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Acute
Patients in acute need for angioplasty or left heart catheterization.
|
|
Chronic or non-acute
Patients will planned angioplasty or left heart catheterization.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients in need of angioplasty or left heart catheterization
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
Contacts and Locations| United States, Ohio | |
| The Ohio State University Medical Center | |
| Columbus, Ohio, United States, 43210 | |
| Principal Investigator: | Quinn Capers IV, MD | Ohio State University |
More Information
No publications provided
| Responsible Party: | Quinn Capers IV, The Ohio State University |
| ClinicalTrials.gov Identifier: | NCT00982852 History of Changes |
| Other Study ID Numbers: | 2008H0112 |
| Study First Received: | January 26, 2009 |
| Last Updated: | April 12, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Ohio State University:
|
Angioplasty Coronary Vessels Heart Disease |
Cardiology Atherosclerosis Catheterization |
Additional relevant MeSH terms:
|
Atherosclerosis Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Failure Infarction Inflammation Myocardial Infarction |
Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Heart Diseases Ischemia Pathologic Processes Necrosis |
ClinicalTrials.gov processed this record on May 19, 2013