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Assessment of Translesional Markers and Metabolomics

This study has been completed.
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
Arshed A. Quyyumi, Emory University
ClinicalTrials.gov Identifier:
NCT00321139
First received: May 1, 2006
Last updated: December 12, 2014
Last verified: September 2014
  Purpose

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.


Condition Phase
Coronary Artery Disease
Phase 4

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: An Assessment of Translesional Markers and Metabolomics

Further study details as provided by Emory University:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

Estimated Enrollment: 50
Study Start Date: April 2006
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  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: NCT00321139

Locations
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Boston Scientific Corporation
Investigators
Principal Investigator: Ziyad B Ghazzal, MD Emory University
  More Information

Responsible Party: Arshed A. Quyyumi, Professor, Emory University
ClinicalTrials.gov Identifier: NCT00321139     History of Changes
Other Study ID Numbers: 1189-2005 
Study First Received: May 1, 2006
Last Updated: December 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
biomarkers
oxidative stress
intravascular ultrasound

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 27, 2016