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Correlation Between Serum Markers of Unstable Plaque and Virtual Histology of Unstable Plaque Visualized by IVUS
This study is currently recruiting participants.
Verified by Ziv Hospital, April 2007
Sponsored by: Ziv Hospital
Information provided by: Ziv Hospital
ClinicalTrials.gov Identifier: NCT00466050
  Purpose

Thirty patients scheduled to coronary angiography and IVUS in according to their treating physician decision will be enrolled in the study. The coronary angiography and IVUS will be done on according to regular clinical standards.

As the study protocol, 40 cc of blood will be drawn from the patients after written informed consent.

The laboratory tests will be processed for the above mentioned serum markers of unstable plaque.

A multivariate correlation test will be done between the different serum markers and the plaque morphology by angiography and composition (virtual histology) by IVUS.


Condition
Acute Coronary Thrombose
Plaque Rupture
Acute Coronary Syndrome

U.S. FDA Resources
Study Type: Observational
Study Design: Screening, Longitudinal, Case Control, Prospective Study
Official Title: Correlation Between Serum Markers of Unstable Plaque and Virtual Histology of Unstable Plaque Visualized by IVUS

Further study details as provided by Ziv Hospital:

Estimated Enrollment: 30
Study Start Date: April 2007
Estimated Study Completion Date: March 2008
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Both genders: males and females
  • Age - above 18 years
  • Patients scheduled to coronary angiography and IVUS
  • Written Informed Consent Form

Exclusion Criteria:

  • Pregnant or breast-feeding woman
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00466050

Contacts
Contact: Osamah Hussein, MD + 972 4 6828943 osama.h@ziv.health.gov.il

Locations
Israel
Heart Institute ,Ziv Medical Center Recruiting
Safed, Israel, 13110
Contact: Jehad Abu Salech, MD     +972 50 84344137     intmeddepta@yahoo.com    
Principal Investigator: Alon Marmor, Prof            
Sub-Investigator: Jehad Abu Salech, MD            
Principal Investigator: Osamah Hussein, MD            
Sponsors and Collaborators
Ziv Hospital
Investigators
Principal Investigator: Osamah Hussein, MD ZIV Medical Center
Principal Investigator: Alon Marmor, Prof Ziv Medical Center
  More Information

Publications:
Davies MJ, Thomas AC. Plaque fissuring--the cause of acute myocardial infarction, sudden ischaemic death, and crescendo angina. Br Heart J. 1985 Apr;53(4):363-73. Review. No abstract available.
Virmani R, Kolodgie FD, Burke AP, Farb A, Schwartz SM. Lessons from sudden coronary death: a comprehensive morphological classification scheme for atherosclerotic lesions. Arterioscler Thromb Vasc Biol. 2000 May;20(5):1262-75. Review. No abstract available.
Frink RJ. Chronic ulcerated plaques: new insights into the pathogenesis of acute coronary disease. J Invasive Cardiol. 1994 Jun;6(5):173-85.
Mann J, Davies MJ. Mechanisms of progression in native coronary artery disease: role of healed plaque disruption. Heart. 1999 Sep;82(3):265-8.
Falk E, Shah PK, Fuster V. Coronary plaque disruption. Circulation. 1995 Aug 1;92(3):657-71. Review. No abstract available.
Schmermund A, Erbel R. Unstable coronary plaque and its relation to coronary calcium. Circulation. 2001 Oct 2;104(14):1682-7. Review.
Giroud D, Li JM, Urban P, Meier B, Rutishauer W. Relation of the site of acute myocardial infarction to the most severe coronary arterial stenosis at prior angiography. Am J Cardiol. 1992 Mar 15;69(8):729-32.
Nobuyoshi M, Tanaka M, Nosaka H, Kimura T, Yokoi H, Hamasaki N, Kim K, Shindo T, Kimura K. Progression of coronary atherosclerosis: is coronary spasm related to progression? J Am Coll Cardiol. 1991 Oct;18(4):904-10.
Klingensmith JD, Vince DG, Kuban BD, Shekhar R, Tuzcu EM, Nissen SE, Cornhill JF. Assessment of coronary compensatory enlargement by three-dimensional intravascular ultrasound. Int J Card Imaging. 2000 Apr;16(2):87-98.
Nissen SE, Gurley JC, Grines CL, Booth DC, McClure R, Berk M, Fischer C, DeMaria AN. Intravascular ultrasound assessment of lumen size and wall morphology in normal subjects and patients with coronary artery disease. Circulation. 1991 Sep;84(3):1087-99.
Schoenhagen P, Ziada KM, Kapadia SR, Crowe TD, Nissen SE, Tuzcu EM. Extent and direction of arterial remodeling in stable versus unstable coronary syndromes : an intravascular ultrasound study. Circulation. 2000 Feb 15;101(6):598-603.
Tuzcu EM, Hobbs RE, Rincon G, Bott-Silverman C, De Franco AC, Robinson K, McCarthy PM, Stewart RW, Guyer S, Nissen SE. Occult and frequent transmission of atherosclerotic coronary disease with cardiac transplantation. Insights from intravascular ultrasound. Circulation. 1995 Mar 15;91(6):1706-13.
von Birgelen C, de Vrey EA, Mintz GS, Nicosia A, Bruining N, Li W, Slager CJ, Roelandt JR, Serruys PW, de Feyter PJ. ECG-gated three-dimensional intravascular ultrasound: feasibility and reproducibility of the automated analysis of coronary lumen and atherosclerotic plaque dimensions in humans. Circulation. 1997 Nov 4;96(9):2944-52.
Palmer ND, Northridge D, Lessells A, McDicken WN, Fox KA. In vitro analysis of coronary atheromatous lesions by intravascular ultrasound; reproducibility and histological correlation of lesion morphology. Eur Heart J. 1999 Dec;20(23):1701-6.
Thieme T, Wernecke KD, Meyer R, Brandenstein E, Habedank D, Hinz A, Felix SB, Baumann G, Kleber FX. Angioscopic evaluation of atherosclerotic plaques: validation by histomorphologic analysis and association with stable and unstable coronary syndromes. J Am Coll Cardiol. 1996 Jul;28(1):1-6.
Waxman S, Sassower MA, Mittleman MA, Zarich S, Miyamoto A, Manzo KS, Muller JE, Abela GS, Nesto RW. Angioscopic predictors of early adverse outcome after coronary angioplasty in patients with unstable angina and non-Q-wave myocardial infarction. Circulation. 1996 Jun 15;93(12):2106-13.
Nicholls SJ, Hazen SL. Myeloperoxidase and cardiovascular disease. Arterioscler Thromb Vasc Biol. 2005 Jun;25(6):1102-11. Epub 2005 Mar 24. Review.
Brennan ML, Penn MS, Van Lente F, Nambi V, Shishehbor MH, Aviles RJ, Goormastic M, Pepoy ML, McErlean ES, Topol EJ, Nissen SE, Hazen SL. Prognostic value of myeloperoxidase in patients with chest pain. N Engl J Med. 2003 Oct 23;349(17):1595-604.
Wald NJ, George L, Smith D, Densem JW, Petterson K. Serum screening for Down's syndrome between 8 and 14 weeks of pregnancy. International Prenatal Screening Research Group. Br J Obstet Gynaecol. 1996 May;103(5):407-12.
Cosin-Sales J, Kaski JC, Christiansen M, Kaminski P, Oxvig C, Overgaard MT, Cole D, Holt DW. Relationship among pregnancy associated plasma protein-A levels, clinical characteristics, and coronary artery disease extent in patients with chronic stable angina pectoris. Eur Heart J. 2005 Oct;26(20):2093-8. Epub 2005 Jul 29.
Bayes-Genis A, Conover CA, Overgaard MT, Bailey KR, Christiansen M, Holmes DR Jr, Virmani R, Oxvig C, Schwartz RS. Pregnancy-associated plasma protein A as a marker of acute coronary syndromes. N Engl J Med. 2001 Oct 4;345(14):1022-9.
Autiero M, Luttun A, Tjwa M, Carmeliet P. Placental growth factor and its receptor, vascular endothelial growth factor receptor-1: novel targets for stimulation of ischemic tissue revascularization and inhibition of angiogenic and inflammatory disorders. J Thromb Haemost. 2003 Jul;1(7):1356-70. Review.
Heeschen C, Dimmeler S, Fichtlscherer S, Hamm CW, Berger J, Simoons ML, Zeiher AM; CAPTURE Investigators. Prognostic value of placental growth factor in patients with acute chest pain. JAMA. 2004 Jan 28;291(4):435-41.
Liuzzo G, Biasucci LM, Gallimore JR, Grillo RL, Rebuzzi AG, Pepys MB, Maseri A. The prognostic value of C-reactive protein and serum amyloid a protein in severe unstable angina. N Engl J Med. 1994 Aug 18;331(7):417-24.
Galis ZS, Sukhova GK, Kranzhofer R, Clark S, Libby P. Macrophage foam cells from experimental atheroma constitutively produce matrix-degrading proteinases. Proc Natl Acad Sci U S A. 1995 Jan 17;92(2):402-6.
Lendon CL, Davies MJ, Born GV, Richardson PD. Atherosclerotic plaque caps are locally weakened when macrophages density is increased. Atherosclerosis. 1991 Mar;87(1):87-90.
Henn V, Slupsky JR, Grafe M, Anagnostopoulos I, Forster R, Muller-Berghaus G, Kroczek RA. CD40 ligand on activated platelets triggers an inflammatory reaction of endothelial cells. Nature. 1998 Feb 5;391(6667):591-4.
Mach F, Schonbeck U, Sukhova GK, Atkinson E, Libby P. Reduction of atherosclerosis in mice by inhibition of CD40 signalling. Nature. 1998 Jul 9;394(6689):200-3.
Heeschen C, Dimmeler S, Hamm CW, van den Brand MJ, Boersma E, Zeiher AM, Simoons ML; CAPTURE Study Investigators. Soluble CD40 ligand in acute coronary syndromes. N Engl J Med. 2003 Mar 20;348(12):1104-11.
Ueda Y, Asakura M, Hirayama A, Komamura K, Hori M, Komada K. Intracoronary morphology of culprit lesions after reperfusion in acute myocardial infarction: serial angioscopic observations. J Am Coll Cardiol. 1996 Mar 1;27(3):606-10.
Mackness MI, Arrol S, Durrington PN. Paraoxonase prevents accumulation of lipoperoxides in low-density lipoprotein. FEBS Lett. 1991 Jul 29;286(1-2):152-4. Erratum in: FEBS Lett 1991 Nov 4;292(1-2):307.
Mackness MI, Arrol S, Abbott C, Durrington PN. Protection of low-density lipoprotein against oxidative modification by high-density lipoprotein associated paraoxonase. Atherosclerosis. 1993 Dec;104(1-2):129-35.
Mackness MI, Abbott C, Arrol S, Durrington PN. The role of high-density lipoprotein and lipid-soluble antioxidant vitamins in inhibiting low-density lipoprotein oxidation. Biochem J. 1993 Sep 15;294 ( Pt 3):829-34.
Mackness MI, Durrington PN. HDL, its enzymes and its potential to influence lipid peroxidation. Atherosclerosis. 1995 Jun;115(2):243-53. Review.

Study ID Numbers: HP-7-234-S
Study First Received: April 25, 2007
Last Updated: April 25, 2007
ClinicalTrials.gov Identifier: NCT00466050  
Health Authority: Israel: Ministry of Health

Keywords provided by Ziv Hospital:
plaque rupture,
acute coronary thrombose,
coronary angiography,
IVUS

Study placed in the following topic categories:
Heart Diseases
Myocardial Ischemia
Acute Coronary Syndrome
Vascular Diseases
 Wounds and Injuries
Disorders of Environmental Origin
Rupture
Ischemia

Additional relevant MeSH terms:
Pathologic Processes
Disease
Syndrome
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009



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