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

January 26, 2009
July 11, 2013
December 2008
July 2009   (final data collection date for primary outcome measure)
Occurrence or absence of adverse cardiovascular outcomes up to 36 months after PCI [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00982852 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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. .

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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.

Non-Probability Sample

Patients in need of angioplasty or left heart catheterization

  • Coronary Artery Disease
  • Atherosclerosis
  • Myocardial Infarction
  • Heart Failure
  • Angina
Not Provided
  • Acute
    Patients in acute need for angioplasty or left heart catheterization.
  • Chronic or non-acute
    Patients will planned angioplasty or left heart catheterization.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
9
December 2010
July 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00982852
2008H0112
No
Quinn Capers, The Ohio State University
Quinn Capers
Not Provided
Principal Investigator: Quinn Capers IV, MD Ohio State University
Ohio State University
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP