Acute Coronary SyndromeNCT01867034
Soluble Receptors for Advanced Glycation End-Products and PCI
A study testing Drug Eluting Stent and Bare Metal Stent in people with Acute Coronary Syndrome, run by University of Saskatchewan at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Drug Eluting Stent and Bare Metal Stent
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2013to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University of Saskatchewan
Saskatoon, Saskatchewan, S7N 0W8
Erick McNair, PhD, 306 222-7403, erick.mcnair@usask.ca
Kailash Prasad, MD,PhD, 306 966-6539, kailash.prasad@usask.ca
About this study
Official title: Soluble Receptors for Advanced Glycation End-Products to Predict the Type of Stent Implant
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.
Read more
The objectives of the study are to determine whether or not:
- Patients with low pre-PCI serum levels of sRAGE who receive bare metal stents develop restenosis
- Patients with high pre-PCI serum levels of sRAGE who receive bare metal stents will have reduced risk of the development of restenosis
- Patients with low pre-PCI serum levels of sRAGE who receive drug eluting stents will have an increased risk of the development of restenosis
Read the 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.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Drug Eluting Stent, Bare Metal Stent
- Keywords
- non ST segment myocardial infarction
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug Eluting StentOther
Comparison of two stents to see which results in best outcome.
Bare Metal StentOther
| Study group | Role | What they receive |
|---|---|---|
| Bare Metal stent | Active comparator | Stent that has not been impregnated with an anti-restenotic drug Receives: Other: Bare Metal Stent |
| Drug Eluting Stent | Active comparator | Stent that has been impregnated with an anti-restenotic drug Receives: Other: Drug Eluting Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
sRAGE
The serum levels of sRAGE will be determined at six months.
Measured: 6-months
Secondary outcomes (1)
coronary restenosis
The patient will have a followup angiogram to determine if restenosis is present.
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erick McNair, PhD, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01867034
- Sponsor's protocol ID
- 5516
- Status last verified
- Mar 2012
- First submitted
- 29 May 2013
- Last updated
- 3 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soluble Receptors for Advanced Glycation End-Products to Predict the Type of Stent Implant
- ClinicalTrials.gov ID
- NCT01867034
- Acronym / sponsor ID
- 5516
- Conditions
- Acute Coronary Syndrome
- Keywords
- non ST segment myocardial infarction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 3 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Patients with low pre-PCI serum levels of sRAGE who receive bare metal stents develop restenosis
- Patients with high pre-PCI serum levels of sRAGE who receive bare metal stents will have reduced risk of the development of restenosis
- Patients with low pre-PCI serum levels of sRAGE who receive drug eluting stents will have an increased risk of the development of restenosis
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bare Metal stent | Active comparator | Other: Bare Metal StentStent that has not been impregnated with an anti-restenotic drug |
| Drug Eluting Stent | Active comparator | Other: Drug Eluting StentStent that has been impregnated with an anti-restenotic drug |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- The reference diameter artery less than 2.5 mm in diameter
- STEMI
- Post-coronary artery bypass graft surgery
- Diabetic
- Coexisting inflammatory diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drug Eluting StentComparison of two stents to see which results in best outcome. | Other | Drug Eluting Stent |
| Bare Metal Stent | Other | Bare Metal stent |
Primary outcome
sRAGE
Time frame: 6-months
The serum levels of sRAGE will be determined at six months.
1 secondary outcome
coronary restenosis
Time frame: 6-months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2013.
Related trials for Acute Coronary Syndrome
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
AI-Assisted Interpretation of Cardiac CT in the Emergency Department
Chest Pain, Acute Coronary Syndrome
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erick McNair, PhD principal investigator
University of Saskatchewan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drug Eluting Stent and Bare Metal Stent in people with Acute Coronary Syndrome, run by University of Saskatchewan at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Erick D. McNair, PhD (306 222-7403, erick.mcnair@usask.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sRAGE (time frame: 6-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2013.