Acute Coronary ThromboseIVUSNCT00466050
Correlation Between Serum Markers of Unstable Plaque and Virtual Histology of Unstable Plaque Visualized by IVUS
An observational study of Acute Coronary Thrombose and Plaque Rupture, run by Ziv Hospital at 1 site in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Thrombose, Plaque Rupture, Acute Coronary Syndrome
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2007to May 2009
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled to coronary angiography and IVUS
Who may be able to join
- Both genders: males and females
- Age - above 18 years
- Patients scheduled to coronary angiography and IVUS
- Written Informed Consent Form
Who cannot join
- Pregnant or breast-feeding woman
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Serum markers of unstable plaque Myeloperoxidase is a lysosomal enzyme, requiring heme as a cofactor, released from neutrophilic granules, monocytes, and some subtypes of tissue macrophages.
Myeloperoxidase is also linked to oxidation of lipids in low-density lipoproteins (LDL), dysfunctional high density lipoproteins (HDL), and consumption of nitric oxide thereby rendering the normally anti-thrombotic endothelial surface thrombogenic via the expression of various pro-thrombotic and anti-fibrinolytic factor (19).
Myeloperoxidase plays a role in the degradation of the fibrous cap, making it both a marker of inflammation and one of plaque instability.
Interest in MPO intensified after a report by Brennan and colleagues (20) indicated that a single initial measurement of plasma myeloperoxidase independently predicts the early risk of myocardial infraction, as well as the risk of major adverse cardiac events in the ensuring 30-day and 6-month periods.
Two markers of recent interest relating to plaque vulnerability pregnancy-associated protein A(PAPP-A) and placenta growth factor (P1GF).
Pregnancy -associated protein A is a metalloproteinase, initially identified in the sera of pregnant women (21).
A large study has illustrated that decreases in IGF-1 appear to be cardio protective, yet some research shows that increases in PAPP-A, which should also increase the bioavailability of IGF-1, may be a relevant marker for the presence and extent of coronary atherosclerosis (22). It is believed that PAPP-A is released during plaque destabilization and appears to be a valuable indicator of unstable angina and acute MI in patients lacking other indicators of necrosis (23).
Placenta growth factor, is a member of the vascular endothelial growth factor family, which stimulates vascular smooth muscle growth, recruits macrophages into atherosclerotic lesion, up-regulates production of tumor necrosis factor- and monocyte chemotactic protein 1 by macrophages, and stimulates pathological angiogenesis (24). It appears to be an initiator of the inflammatory process.
In one study, elevated P1GF levels not only identified patients with acute chest pain who developed ACS, but also those patients with an increased risk of recurrent instability after hospital discharge (25).
Plasma elevation of CRP have been reported fraction, and are acute ischemia and myocardial in fraction, and are predictive of the risk of recurrent ischemia among hospitalization patients with unstable angina (26).
Matrix metalloproteinases. MMPs are a diverse family of powerful, zinc-containing enzymes expressed by macrophage- derived foam cells, SMCs and other vascular cells within atherosclerotic lesions (27) .It has been previously demonstrated that MMPs are responsible for remodeling of the ECM during all stages of atheromatous development and may directly contribute to fibrous cap weakening and plaque rupture within disease arteries (28).
CD40 ligand (CD40L) is an immunoregulatory transmembrane protein that belongs to the tumor necrosis factor (TNF) super family. It is expressed on the surface of many cells types, including leukocytes, ECs, SMSs, macrophages, and activated platelets (29). Ligand receptor binding on these cells triggers the expression and secretion of a variety of pro-inflammatory and procoagulant mediators, including CAMs, cytokines, chemokines, growth factors, MMPs, and TF (29). Recent data suggest that CD40L plays a central role in the inflammatory process that contributes to plaque destabilization in CAD (30), and elevation in soluble, biologically active CD40L (Scd40l) have been demonstrated in the serum of ACS patients (31).
Paraoxonase and atherogenic HDL The enzyme PON1 is known to be tightly bound with HDL in serum, and several studies suggest that it is this association that contributes to the protection conferred by HDL against LDL oxidation (33-36).
The aim of the study is to find a correlation between serum markers of unstable plaque and virtual histology of unstable plaque visualized by IVUS.
Patients and methods:
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.
- Keywords
- plaque rupture,, acute coronary thrombose,, coronary angiography,, IVUS
- Medical subject headings
- Acute Coronary Syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2007 (estimated)
- Study startApr 2007
- Primary completionApr 2008
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary ThromboseStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziv Hospital
- Sponsor type
- Other government
- Investigators
- Osamah Hussein, MD, Principal investigator, Ziv Medical CenterAlon Marmor, Prof, Principal investigator, Ziv Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00466050
- Sponsor's protocol ID
- HP-7-234-S
- Acronym
- IVUS
- Status last verified
- Apr 2007
- First submitted
- 25 Apr 2007
- Last updated
- 25 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1136/hrt.53.4.363. No abstract available.
PubMed 3885978Virmani 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. doi: 10.1161/01.atv.20.5.1262. No abstract available.
PubMed 10807742Frink RJ. Chronic ulcerated plaques: new insights into the pathogenesis of acute coronary disease. J Invasive Cardiol. 1994 Jun;6(5):173-85.
PubMed 10155066Mann J, Davies MJ. Mechanisms of progression in native coronary artery disease: role of healed plaque disruption. Heart. 1999 Sep;82(3):265-8. doi: 10.1136/hrt.82.3.265.
PubMed 10455072Falk E, Shah PK, Fuster V. Coronary plaque disruption. Circulation. 1995 Aug 1;92(3):657-71. doi: 10.1161/01.cir.92.3.657. No abstract available.
PubMed 7634481Schmermund A, Erbel R. Unstable coronary plaque and its relation to coronary calcium. Circulation. 2001 Oct 2;104(14):1682-7. doi: 10.1161/hc3901.093339.
PubMed 11581149Giroud 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. doi: 10.1016/0002-9149(92)90495-k.
PubMed 1546645Nobuyoshi 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. doi: 10.1016/0735-1097(91)90745-u.
PubMed 1894863Klingensmith 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. doi: 10.1023/a:1006333619358.
PubMed 10928343Nissen 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. doi: 10.1161/01.cir.84.3.1087.
PubMed 1884441Schoenhagen 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. doi: 10.1161/01.cir.101.6.598.
PubMed 10673250Tuzcu 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. doi: 10.1161/01.cir.91.6.1706.
PubMed 7882477von 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. doi: 10.1161/01.cir.96.9.2944.
PubMed 9386161Palmer 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. doi: 10.1053/euhj.1999.1627.
PubMed 10562477Thieme 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. doi: 10.1016/0735-1097(96)00108-8.
PubMed 8752786
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Serum Markers of Unstable Plaque and Virtual Histology of Unstable Plaque Visualized by IVUS
- ClinicalTrials.gov ID
- NCT00466050
- Acronym / sponsor ID
- IVUS / HP-7-234-S
- Keywords
- plaque rupture,, acute coronary thrombose,, coronary angiography,, IVUS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ziv HospitalOther government
- Study start
- Apr 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 27 Apr 2007 (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.
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.
Detailed description
Serum markers of unstable plaque Myeloperoxidase is a lysosomal enzyme, requiring heme as a cofactor, released from neutrophilic granules, monocytes, and some subtypes of tissue macrophages.
Myeloperoxidase is also linked to oxidation of lipids in low-density lipoproteins (LDL), dysfunctional high density lipoproteins (HDL), and consumption of nitric oxide thereby rendering the normally anti-thrombotic endothelial surface thrombogenic via the expression of various pro-thrombotic and anti-fibrinolytic factor (19).
Myeloperoxidase plays a role in the degradation of the fibrous cap, making it both a marker of inflammation and one of plaque instability.
Interest in MPO intensified after a report by Brennan and colleagues (20) indicated that a single initial measurement of plasma myeloperoxidase independently predicts the early risk of myocardial infraction, as well as the risk of major adverse cardiac events in the ensuring 30-day and 6-month periods.
Two markers of recent interest relating to plaque vulnerability pregnancy-associated protein A(PAPP-A) and placenta growth factor (P1GF).
Pregnancy -associated protein A is a metalloproteinase, initially identified in the sera of pregnant women (21).
A large study has illustrated that decreases in IGF-1 appear to be cardio protective, yet some research shows that increases in PAPP-A, which should also increase the bioavailability of IGF-1, may be a relevant marker for the presence and extent of coronary atherosclerosis (22). It is believed that PAPP-A is released during plaque destabilization and appears to be a valuable indicator of unstable angina and acute MI in patients lacking other indicators of necrosis (23).
Placenta growth factor, is a member of the vascular endothelial growth factor family, which stimulates vascular smooth muscle growth, recruits macrophages into atherosclerotic lesion, up-regulates production of tumor necrosis factor- and monocyte chemotactic protein 1 by macrophages, and stimulates pathological angiogenesis (24). It appears to be an initiator of the inflammatory process.
In one study, elevated P1GF levels not only identified patients with acute chest pain who developed ACS, but also those patients with an increased risk of recurrent instability after hospital discharge (25).
Plasma elevation of CRP have been reported fraction, and are acute ischemia and myocardial in fraction, and are predictive of the risk of recurrent ischemia among hospitalization patients with unstable angina (26).
Matrix metalloproteinases. MMPs are a diverse family of powerful, zinc-containing enzymes expressed by macrophage- derived foam cells, SMCs and other vascular cells within atherosclerotic lesions (27) .It has been previously demonstrated that MMPs are responsible for remodeling of the ECM during all stages of atheromatous development and may directly contribute to fibrous cap weakening and plaque rupture within disease arteries (28).
CD40 ligand (CD40L) is an immunoregulatory transmembrane protein that belongs to the tumor necrosis factor (TNF) super family. It is expressed on the surface of many cells types, including leukocytes, ECs, SMSs, macrophages, and activated platelets (29). Ligand receptor binding on these cells triggers the expression and secretion of a variety of pro-inflammatory and procoagulant mediators, including CAMs, cytokines, chemokines, growth factors, MMPs, and TF (29). Recent data suggest that CD40L plays a central role in the inflammatory process that contributes to plaque destabilization in CAD (30), and elevation in soluble, biologically active CD40L (Scd40l) have been demonstrated in the serum of ACS patients (31).
Paraoxonase and atherogenic HDL The enzyme PON1 is known to be tightly bound with HDL in serum, and several studies suggest that it is this association that contributes to the protection conferred by HDL against LDL oxidation (33-36).
The aim of the study is to find a correlation between serum markers of unstable plaque and virtual histology of unstable plaque visualized by IVUS.
Patients and methods:
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled to coronary angiography and IVUS
Key inclusion criteria (4 listed)
- Both genders: males and females
- Age - above 18 years
- Patients scheduled to coronary angiography and IVUS
- Written Informed Consent Form
Key exclusion criteria (1 listed)
- Pregnant or breast-feeding woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2009.
- Background: PubMed 3885978Davies 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. doi: 10.1136/hrt.53.4.363. No abstract available.
- Background: PubMed 10807742Virmani 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. doi: 10.1161/01.atv.20.5.1262. No abstract available.
- Background: PubMed 10155066Frink RJ. Chronic ulcerated plaques: new insights into the pathogenesis of acute coronary disease. J Invasive Cardiol. 1994 Jun;6(5):173-85.
- Background: PubMed 10455072Mann J, Davies MJ. Mechanisms of progression in native coronary artery disease: role of healed plaque disruption. Heart. 1999 Sep;82(3):265-8. doi: 10.1136/hrt.82.3.265.
- Background: PubMed 7634481Falk E, Shah PK, Fuster V. Coronary plaque disruption. Circulation. 1995 Aug 1;92(3):657-71. doi: 10.1161/01.cir.92.3.657. No abstract available.
- Background: PubMed 11581149Schmermund A, Erbel R. Unstable coronary plaque and its relation to coronary calcium. Circulation. 2001 Oct 2;104(14):1682-7. doi: 10.1161/hc3901.093339.
- Background: PubMed 1546645Giroud 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. doi: 10.1016/0002-9149(92)90495-k.
- Background: PubMed 1894863Nobuyoshi 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. doi: 10.1016/0735-1097(91)90745-u.
- Background: PubMed 10928343Klingensmith 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. doi: 10.1023/a:1006333619358.
- Background: PubMed 1884441Nissen 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. doi: 10.1161/01.cir.84.3.1087.
- Background: PubMed 10673250Schoenhagen 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. doi: 10.1161/01.cir.101.6.598.
- Background: PubMed 7882477Tuzcu 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. doi: 10.1161/01.cir.91.6.1706.
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.
Osamah Hussein, MD principal investigator
Ziv Medical Center
Alon Marmor, Prof principal investigator
Ziv Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Thrombose and Plaque Rupture, run by Ziv Hospital at 1 site in Israel.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 25 Aug 2009. 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 Israel. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00466050, which also lists 34 linked publications.
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 25 Aug 2009.