Physical,Histological,and Genetic Analyses of Lipid-rich... | NCT00449306

Studies
Physical,Histological,and Genetic Analyses of Lipid-rich Atherosclerotic Plaques

NCT00449306

Sponsor

Sheba Medical Center

Status

Unknown status

Last Update Posted

Jul 5, 2019Actual

Enrollment

120Estimated

Phase

Not provided

Conditions

Atherosclerosis
Aortic Aneurysm
Peripheral Vascular Diseases

Interventions

Not provided

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2001

Primary Completion Date

Jul 2021Estimated

Completion Date

Jul 2021Estimated

First Submitted Date

Mar 19, 2007

First Submission Date that Met QC Criteria

Mar 19, 2007

First Posted Date

Mar 20, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 3, 2019

Last Update Posted Date

Jul 5, 2019Actual

Name	Class
University Hospital Goettingen	OTHER
Carmel Medical Center	OTHER
CVPath Institute Inc.	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Lipid-rich atherosclerotic plaques, or "vulnerable plaques" are prone to rupture, causing local intravascular thrombosis, with subsequent grave clinical consequences. Atherosclerotic plaques normally removed during surgery, and peripheral blood samples will be studied to achieve the following objectives:

"1" Define histological features of the vulnerable plaque, analyze its physical characteristics, and investigate selected gene expression.

"2" Study biomarkers of inflammation in conjunction with the presence of vulnerable plaques.

"3" Explore the potential role of infection in atherogenesis.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

120Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To uncover mechanisms of cardiovascular diseases		3 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Evidence of symptomatic carotid stenosis exceeding 60%(TIAs or stroke within the last 6 months), and asymptomatic carotid artery stenosis (presenting with progressive carotid stenosis, exceeding 70%)
Abdominal aortic aneurysm, and aortic occlusive disease
Peripheral occlusive or aneurysmal disease

Exclusion Criteria:

Non-compliant patients, incapable of granting approval by informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Primary Care Clinic patients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jacob Schneiderman, MD	Department of Vascular Surgery, Sheba Medical Center, Tel Hashomer	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sheba Medical Center, Tel Hashomer		Ramat Gan		52621	Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27143353	Derived	Ben-Zvi D, Savion N, Kolodgie F, Simon A, Fisch S, Schafer K, Bachner-Hinenzon N, Cao X, Gertler A, Solomon G, Kachel E, Raanani E, Lavee J, Kotev Emeth S, Virmani R, Schoen FJ, Schneiderman J. Local Application of Leptin Antagonist Attenuates Angiotensin II-Induced Ascending Aortic Aneurysm and Cardiac Remodeling. J Am Heart Assoc. 2016 May 3;5(5):e003474. doi: 10.1161/JAHA.116.003474.
23316287

ID	Term
D050197	Atherosclerosis
D001014	Aortic Aneurysm
D016491	Peripheral Vascular Diseases
D017544	Aortic Aneurysm, Abdominal
D002340	Carotid Artery Diseases

ID	Term
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases