Intravascular Ultrasound Derived Virtual Histology and Intracoronary Serum Markers of Inflammation

Coronary Artery Disease Clinical Trial

Official title:

Intravascular Ultrasound Derived Virtual Histology and Intracoronary Serum Markers of Inflammation in Patients Referred for Percutaneous Coronary Intervention.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00982852
• Other study ID #: 2008H0112
• Status: Terminated
• Phase: N/A
• First received: January 26, 2009
• Last updated: July 11, 2013
• Start date: December 2008
• Est. completion date: December 2010

Study information

• Verified date: July 2013
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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. .

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: December 2010
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Angina
• Atherosclerosis
• Coronary Artery Disease
• Coronary Disease
• Heart Failure
• Myocardial Infarction
• Myocardial Ischemia

Locations

Country	Name	City	State
United States	The Ohio State University Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Quinn Capers

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence or absence of adverse cardiovascular outcomes up to 36 months after PCI		36 months	No