Coronary Artery Disease Clinical Trial
Official title:
Matrix Metalloproteinases Expression in the Neointimal Hyperplasia Induced by Drug Eluting Stent (DES) Implantation
If intimal growth is such that the initial lumen is narrowed significantly, distal blood flow
is restricted and chronic tissue ischemia results. This occurs in native coronary arteries
and during restenosis after coronary angioplasty or failure of some coronary vein grafts.
Stent implantation has become the principal revascularization technique for coronary artery
disease. But, in-stent restenosis (ISR) by neointimal hyperplasia persists as a significant
limitation of this procedure in the era of drug eluting stent (DES). Coronary intervention
might induce an inflammatory response by arterial wall damage, release of inflammatory and
chemoattractant factors resulting in leukocyte and platelet activation. Then, Migration and
proliferation of neointimal smooth muscle cells together with the deposition of extracellular
matrix might lead to the development of ISR.
It is known that matrix metalloproteinases (MMPs) play a key role in the pathogenesis of
restenosis by controlling extracellular matrix degradation and the release of
matrix-degrading MMPs, including MMP -2 and MMP-9, which facilitate intimal remodeling after
angioplasty. Previous studies showed that increased levels of MMPs in coronary arteries
undergoing percutaneous intervention may be associated with vascular remodeling and
restenosis by promoting migration of vascular smooth muscle cells. Recently, Gregory et al.
demonstrated that elevated serum activities of MMP-2 and -9 are associated with dramatically
increased restenosis rates after PCI with implantation of DES.
In patients with DESs, determination of MMP levels might be useful for identification of
patients who are at high risk for ISR. However, not much is known about the relationship
between MMPs and neointimal hyperplasia in patients with DES. In this study, the serum
activity of MMP-2 and 9 were investigated in patients who had undergone follow-up coronary
angiography with intravascular ultrasound (IVUS), which performed at 9 months post-DES
implantation. Our aim was to evaluate if individual or combined levels of MMPs were
associated with increased neointimal hyperplasia volume, that is, to evaluate the
relationship, correlation between the levels of MMPs and neointimal hyperplasia volume.
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | May 1, 2019 |
Est. primary completion date | January 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 90 Years |
Eligibility |
Inclusion Criteria: - Ischemic heart disease Exclusion Criteria: - Left main coronary artery disease (defined as a stenosis of > 50%) - Prior complex lesion morphologies (aorto-ostial, bifurcation with >2.0 mm side branch, severe calcification, chronic total occlusion) - Long lesion that require more than two stents - Inflammatory conditions likely to be associated with an acute phase response, autoimmune and neoplastic disease - Advanced liver disease, renal failure, and valvular heart disease - If there was persistent cardiogenic shock, refractory pulmonary edema, or hemodynamic instability (blood pressure <90/50 mmHg). |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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Dankook University |
Katsaros KM, Kastl SP, Zorn G, Maurer G, Wojta J, Huber K, Christ G, Speidl WS. Increased restenosis rate after implantation of drug-eluting stents in patients with elevated serum activity of matrix metalloproteinase-2 and -9. JACC Cardiovasc Interv. 2010 Jan;3(1):90-7. doi: 10.1016/j.jcin.2009.10.023. — View Citation
Schoenhagen P, Vince DG, Ziada KM, Kapadia SR, Lauer MA, Crowe TD, Nissen SE, Tuzcu EM. Relation of matrix-metalloproteinase 3 found in coronary lesion samples retrieved by directional coronary atherectomy to intravascular ultrasound observations on coronary remodeling. Am J Cardiol. 2002 Jun 15;89(12):1354-9. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Matrix Metalloproteinase expression correlate with neointimal plaque volume measure by intravascular ultrasound at 12 months follow up coronary angiography | Endogenous MMP-2 and MMP-9 were measured in serum using a standardized enzyme-linked immunosorbent assay (ELISA; R&D systems). This system measures the endogenous activity of the specific MMPs. Neointimal plaque volume measure by intravascular ultrasound at 12 months follow up coronary angiography | One time frame - MMP sampling at 12 month follow up coronary angiography. |
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