Assessment of Translesional Markers and Metabolomics

NCT00321139 | Completed

• 1 other identifier: 1189-2005
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Blockages in the blood vessels of the heart are the main cause of chest pain, heart attacks, and sudden death. A cardiac catheterization, or injecting x-ray dye into the blood vessels of the heart and taking pictures, is currently the best way of assessing these blockages. This procedure, however, does not allow us to know what is happening inside the blockages. Some blockages have a higher risk of "rupturing" and completely blocking of the blood vessel while others are at low risk for doing this. Blood levels of different substances produced by the body have been shown to be associated with a higher risk of having chest pain, a heart attack, or sudden death. There is also evidence from studies in animals and tissues taken from humans during surgery that some of these substances are made in the blockages themselves. We would like to investigate whether a number of these substances are made in the blockages and released into the bloodstream. We will do this by taking one tablespoon samples of blood upstream and downstream of the blockages in the blood vessels of the heart. The samples will be obtained by using a very thin catheter, or plastic tubing, that is about 1/3 the size of the blood vessels of the heart. We will take samples from the tightest blockage found as well as another, less tight, blockage and compare the two. We will also sample blood from the tightest blockage after it is opened by doing an angioplasty. Finally, we will also take pictures of the blockages studied using a very small ultrasound camera inserted into the blood vessel. We will compare the levels of the substances measured with the features we see on the pictures. We hope to learn if some or all of the substances measured can identify which blockages are more at risk for rupturing and causing heart attacks and sudden death. All patients who are entered into this study will already be having an angioplasty done. The procedures needed for the study (sampling of blood and taking pictures with an ultrasound) are already often, though not always, used in patients undergoing an angioplasty.

Conditions

Coronary Artery Disease

Keywords

biomarkers; oxidative stress; intravascular ultrasound

Outcome Measures

Primary Outcomes (4)

• A comparison of the markers of oxidation, inflammation, and leucocyte activation in the following:

• A comparison will be made between the translesional marker gradients (distal level - proximal level) of samples from the culprit lesion and non-culprit lesion.

• A comparison will be made between levels (distal level - proximal level) to the culprit lesion before and after angioplasty/stenting.

• 3. A

Secondary Outcomes (2)

• A comparison of the markers of oxidation, inflammation, and leucocyte activation with plaque morphologic indices as assessed by intravascular ultrasound.

• comparison of 1H-NMR metabolomic spectra from culprit and non-culprit lesions as well as plaques that have high-risk and low-risk plaque morphologies.

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women from the ages of 21 and older
• Able to give informed consent
• Already scheduled to undergo diagnostic catheterization or percutaneous coronary intervention
• A culprit lesion (\>60% diameter stenosis) in an artery that is at least 2.5 mm in diameter immediately proximal to the lesion.
• Presence of a second, non-culprit lesion, that is between 20 and 60% diameter stenosis in an artery that is at least 2.5 mm in diameter immediately proximal to the lesion.

You may not qualify if:

• ST-segment elevation myocardial infarction
• Thrombolysis in Myocardial Infarction (TIMI) grade 0 flow in the vessel containing the culprit lesion
• Autoimmune diseases, malignancy, or with active infections
• Taking immune-modulating therapies, eg prednisone
• Culprit lesion is in-stent restenosis
• Culprit lesion cannot be crossed with a wire and/or balloon
• Those enrolled in another research study

Sponsors & Collaborators

• Emory University: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Ziyad B Ghazzal, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 1, 2006
• First Posted: May 3, 2006
• Study Start: April 1, 2006
• Primary Completion: January 1, 2007
• Last Updated: December 15, 2014

Record last verified: 2014-09

Locations

US (1)