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Soluble Receptors for Advanced Glycation End-Products and PCI

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ClinicalTrials.gov Identifier: NCT01867034
Recruitment Status : Unknown
Verified March 2012 by University of Saskatchewan.
Recruitment status was:  Recruiting
First Posted : June 3, 2013
Last Update Posted : June 3, 2013
Sponsor:
Information provided by (Responsible Party):
University of Saskatchewan

Brief Summary:

It is hypothesized that patients with low pre-PCI serum levels of sRAGE should receive DES implantation and/ or procedures taken to increase serum levels of sRAGE and/ or decrease the serum levels of AGE.

The purpose of this pilot study is to afford invasive cardiologists with additional evidenced based information to guide their decision as to which patients should receive a BMS or DES for coronary implantation.

The objectives of the study are to determine whether or not:

  1. Patients with low pre-PCI serum levels of sRAGE who receive bare metal stents develop restenosis
  2. Patients with high pre-PCI serum levels of sRAGE who receive bare metal stents will have reduced risk of the development of restenosis
  3. Patients with low pre-PCI serum levels of sRAGE who receive drug eluting stents will have an increased risk of the development of restenosis

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Other: Drug Eluting Stent Other: Bare Metal Stent Not Applicable

Detailed Description:

Advanced glycation end products (AGE) are irreversible adducts formed from the non-enzymatic glycation and oxidation of proteins, lipids and nucleic acids. 1-4 AGE interacts with three types of cell receptors for advanced glycation end products (RAGE) namely full-length RAGE, N-truncated and C-truncated soluble receptors for AGE (sRAGE). The interaction of full-length RAGE with AGE increases the expression of adhesion molecules, including soluble vascular cell adhesion molecule-1 (sVCAM-1) and the cytokine tumor necrosis factor-α (TNF- α) activation of nuclear factor kappa B (NFκB) which in turn increases the expression of proinflammatory genes for adhesion molecules and cytokines, and the generation of reactive oxygen species (ROS). The function of N-truncated RAGE is poorly understood. sRAGE is not membrane bound and circulates in the plasma. Acting as a decoy for RAGE ligands (AGE), sRAGE competes with full-length RAGE for ligand binding. Consequently, sRAGE plays a protective role by preventing activation of full-length RAGE.

Adhesion molecules, cytokines, and ROS are involved in the development and progression of atherosclerosis and lesion instability. The AGE and RAGE axis is involved in the development atherosclerosis in diabetes. Balloon injury in carotid artery and endothelial denudation in animal models increases the levels of RAGE and AGE in the arterial wall and produce neointimal hyperplasia. Treatment with sRAGE in animal models reduces neointimal growth, decreases smooth muscle cell proliferation and migration, and expression of extracellular matrix. sRAGE reduces the atherosclerotic lesions in Apo-E -/- mice and this effect is associated with a decrease in aortic VCAM-1 and tissue factor.

Recently, we have demonstrated that the levels of serum sRAGE are lower while the serum levels of AGE, sVCAM-1 and TNF-α are higher in subjects with NSTEMI as compared to healthy controls 31. Furthermore, we have shown that the NSTEMI patients, who underwent PCI with BMS implantation and developed post-PCI restenosis after six-months, had lower serum levels of sRAGE as compared to those who did not 30. In the proposed study we expect to find that all patients with very low levels of serum sRAGE receiving either a BMS develop post-PCI restenosis while patients with very low serum levels of sRAGE receiving DES will increased rate of post-PCI restenosis. In addition, those patients with high levels of sRAGE who receive either BMS or DES will have a reduced rate of restenosis.

This study has clinical significance because in our previous study (McNair et al, 2010), we demonstrated that low serum levels of sRAGE are associated with 100% restenosis following BMS implantation. In these situations DES implantation will be highly beneficial.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Soluble Receptors for Advanced Glycation End-Products to Predict the Type of Stent Implant
Study Start Date : March 2013
Estimated Primary Completion Date : March 2015
Estimated Study Completion Date : June 2015

Arm Intervention/treatment
Active Comparator: Bare Metal stent
Stent that has not been impregnated with an anti-restenotic drug
Other: Bare Metal Stent
Active Comparator: Drug Eluting Stent
Stent that has been impregnated with an anti-restenotic drug
Other: Drug Eluting Stent
Comparison of two stents to see which results in best outcome.




Primary Outcome Measures :
  1. sRAGE [ Time Frame: 6-months ]
    The serum levels of sRAGE will be determined at six months.


Secondary Outcome Measures :
  1. coronary restenosis [ Time Frame: 6-months ]
    The patient will have a followup angiogram to determine if restenosis is present.



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with NSTEMI
  • Discrete denovo localized lesions in single or multiple vessel
  • Non-diabetic
  • EF> 40%
  • Patients willing to come back for a follow-up angiogram 6 months post -PCI

Exclusion Criteria:

  • The reference diameter artery less than 2.5 mm in diameter
  • STEMI
  • Post-coronary artery bypass graft surgery
  • Diabetic
  • Coexisting inflammatory diseases
  • Coexisting valvular disease
  • Patients with a history of substance abuse

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01867034


Contacts
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Contact: Erick D. McNair, PhD 306 222-7403 erick.mcnair@usask.ca
Contact: Kailash Prasad, MD, PhD 306 966-6539 kailash.prasad@usask.ca

Locations
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Canada, Saskatchewan
University of Saskatchewan Recruiting
Saskatoon, Saskatchewan, Canada, S7N 0W8
Contact: Erick McNair, PhD    306 222-7403    erick.mcnair@usask.ca   
Contact: Kailash Prasad, MD,PhD    306 966-6539    kailash.prasad@usask.ca   
Sponsors and Collaborators
University of Saskatchewan
Investigators
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Principal Investigator: Erick McNair, PhD University of Saskatchewan
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Responsible Party: University of Saskatchewan
ClinicalTrials.gov Identifier: NCT01867034    
Other Study ID Numbers: 5516
First Posted: June 3, 2013    Key Record Dates
Last Update Posted: June 3, 2013
Last Verified: March 2012
Keywords provided by University of Saskatchewan:
non ST segment myocardial infarction
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases