Intravascular Ultrasound Derived Virtual Histology and Intracoronary Serum Markers of Inflammation

This study has been terminated.
(Lack of funding)
Sponsor:
Information provided by (Responsible Party):
Quinn Capers, The Ohio State University
ClinicalTrials.gov Identifier:
NCT00982852
First received: January 26, 2009
Last updated: July 11, 2013
Last verified: July 2013
  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.

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • 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.


Enrollment: 9
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
Study Population

Patients in need of angioplasty or left heart catheterization

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00982852

Locations
United States, Ohio
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Quinn Capers
Investigators
Principal Investigator: Quinn Capers IV, MD Ohio State University
  More Information

No publications provided

Responsible Party: Quinn Capers, Professor, The Ohio State University
ClinicalTrials.gov Identifier: NCT00982852     History of Changes
Other Study ID Numbers: 2008H0112
Study First Received: January 26, 2009
Last Updated: July 11, 2013
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
Arteriosclerosis
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Failure
Infarction
Inflammation
Myocardial Infarction
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Heart Diseases
Ischemia
Pathologic Processes
Necrosis

ClinicalTrials.gov processed this record on August 19, 2014