Intravascular Ultrasound Derived Virtual Histology and Intracoronary Serum Markers of Inflammation

NCT00982852 | Terminated

• 1 other identifier: 2008H0112
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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. .

Conditions

Coronary Artery Disease; Atherosclerosis; Myocardial Infarction; Heart Failure; Angina

Keywords

Angioplasty; Coronary Vessels; Heart Disease; Cardiology; Atherosclerosis; Catheterization

Outcome Measures

Primary Outcomes (1)

• Occurrence or absence of adverse cardiovascular outcomes up to 36 months after PCI

  36 months

Study Arms (2)

Acute

Patients in acute need for angioplasty or left heart catheterization.

Chronic or non-acute

Patients will planned angioplasty or left heart catheterization.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients in need of angioplasty or left heart catheterization

You may qualify if:

• In- or out-patients admitted to IPR or hospital floor for left heart catheterization or scheduled angioplasty
• years or older
• Able to provide informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Quinn Capers: lead

Study Sites (1)

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

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.

MeSH Terms

Conditions

Coronary Artery Disease; Atherosclerosis; Myocardial Infarction; Heart Failure; Angina Pectoris; Heart Diseases

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Quinn Capers IV, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 26, 2009
• First Posted: September 23, 2009
• Study Start: December 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: December 1, 2010
• Last Updated: July 12, 2013

Record last verified: 2013-07

Locations

US (1)