MedDataX Logo

Effects of Low-density Lipoprotein (LDL) Apheresis on Inflammatory and Lipid Markers

NCT ID: NCT01138371

Last Updated: 2013-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The primary objective of this study is to measure how LDL apheresis affects levels of inflammatory and cholesterol markers in human beings. The investigators will address this question by drawing pre- and post-LDL apheresis blood from patients who are undergoing this procedure. A secondary objective of this study is to learn how specific inflammatory markers behave in our blood in terms of time to rebound back to normal levels. The investigators will address this question by drawing post-LDL apheresis blood at predetermined time intervals.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Numerous epidemiological investigations have demonstrated the importance of cholesterol - specifically low density lipoprotein (LDL) - in the development and progression of atherosclerosis. A continuing relationship between cholesterol level and coronary morbidity has been established. The initial approach for managing elevated cholesterol includes lifestyle interventions, namely eating a low fat diet, weight loss in overweight patients, and regular aerobic exercise. Once lifestyle interventions have been applied, pharmacologic therapy becomes a mainstay of therapy, conventionally with a statin followed by adjunctive medicines as indicated. Certain populations that are refractory to aggressive pharmacotherapy, however - such as patients who have familial hypercholesterolemia (FH) - necessitate alternative means of lipid management. Therapeutic considerations in these patients include LDL apheresis and a number of rare procedures such as partial ileal bypass, liver transplantation, portocaval shunting, and possibly gene therapy in the future.

The anti-inflammatory effects of LDL apheresis and its effects on endothelial function are not well known. Considering several pathways of atherogenesis, and inflammation as a central mechanism thereof, LDL apheresis may theoretically provide synergistic benefit of lipid lowering as well as proinflammatory agent lowering that can lead to significantly decreased atherogenesis. This study looks to address these questions by assessing the effects of LDL apheresis on inflammatory and lipid markers.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Familial Hypercholesterolemia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

LDL apheresis Familial hypercholesterolemia Inflammatory markers Hyperlipidemia Cardiovascular disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Familial hypercholesterolemia

* Heterozygous FH with documented CAD and LDL-C ≥ 200 mg/dL (Documented CAD may be represented as: Lesion(s) on coronary angiography, history of myocardial infarction, CABG, PTCA, progressive angina demonstrated by stress testing, history of other revascularization procedure)
* Homozygous FH and LDL-C \> 500 mg/dL
* Heterozygous FH and LDL-C ≥ 300 mg/dL
* On stable LDL apheresis therapy for at least 6 months

LDL Apheresis

Intervention Type PROCEDURE

LDL Apheresis

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

LDL Apheresis

LDL Apheresis

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Apheresis LDL filtration

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Heterozygous FH with documented CAD and LDL-C ≥ 200 mg/dL Documented CAD may be represented as: Lesion(s) on coronary angiography, history of myocardial infarction, CABG, PTCA, progressive angina demonstrated by stress testing, history of other revascularization procedure (e.g. atherectomy)
* Homozygous FH and LDL-C \> 500 mg/dL
* Heterozygous FH and LDL-C ≥ 300 mg/dL
* On stable LDL apheresis therapy for at least 6 months.

Exclusion Criteria

* Patient refusal to participate
* Inability to attend 2 consecutive LDL apheresis sessions for study duration
* Subject with advanced renal disease
* Subject with chronic progressive hepatic disease and demonstrated deficient synthetic function
* Subject with acute hepatic process
* Subject with current malignancy
* Subject with diagnosis of amyloidosis
* Subject with diagnosis of rheumatoid arthritis
* Any subject with acute flare of chronic disease
* Subject with recent ethanol ingestion
* Subject with significant bone disease
Minimum Eligible Age

3 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kaneka Medical America LLC

INDUSTRY

Sponsor Role collaborator

Emory University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Laurence Sperling, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Vimal Ramjee, MD

Role: STUDY_DIRECTOR

Emory University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Emory University Hospital

Atlanta, Georgia, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Napoli C, Ambrosio G, Scarpato N, Corso G, Palumbo G, D'Armiento FP, Mancini FP, Malorni A, Formisano S, Ruocco A, Cali A, Chiariello M. Decreased low-density lipoprotein oxidation after repeated selective apheresis in homozygous familial hypercholesterolemia. Am Heart J. 1997 May;133(5):585-95. doi: 10.1016/s0002-8703(97)70155-8.

Reference Type BACKGROUND
PMID: 9141382 (View on PubMed)

Mehta PK, Baer J, Nell C, Sperling LS. Low-density lipoprotein apheresis as a treatment option for hyperlipidemia. Curr Treat Options Cardiovasc Med. 2009 Aug;11(4):279-88. doi: 10.1007/s11936-009-0029-1.

Reference Type BACKGROUND
PMID: 19627661 (View on PubMed)

Mabuchi H, Higashikata T, Kawashiri MA. Clinical applications of long-term LDL-apheresis on and beyond refractory hypercholesterolemia. Transfus Apher Sci. 2004 Jun;30(3):233-43. doi: 10.1016/j.transci.2004.01.006.

Reference Type BACKGROUND
PMID: 15172629 (View on PubMed)

Thompson GR. LDL apheresis. Atherosclerosis. 2003 Mar;167(1):1-13. doi: 10.1016/s0021-9150(02)00251-4.

Reference Type BACKGROUND
PMID: 12618263 (View on PubMed)

Thompson GR, Maher VM, Matthews S, Kitano Y, Neuwirth C, Shortt MB, Davies G, Rees A, Mir A, Prescott RJ, et al. Familial Hypercholesterolaemia Regression Study: a randomised trial of low-density-lipoprotein apheresis. Lancet. 1995 Apr 1;345(8953):811-6. doi: 10.1016/s0140-6736(95)92961-4.

Reference Type BACKGROUND
PMID: 7898227 (View on PubMed)

Kroon AA, Aengevaeren WR, van der Werf T, Uijen GJ, Reiber JH, Bruschke AV, Stalenhoef AF. LDL-Apheresis Atherosclerosis Regression Study (LAARS). Effect of aggressive versus conventional lipid lowering treatment on coronary atherosclerosis. Circulation. 1996 May 15;93(10):1826-35. doi: 10.1161/01.cir.93.10.1826.

Reference Type BACKGROUND
PMID: 8635262 (View on PubMed)

Igarashi K, Tsuji M, Nishimura M, Horimoto M. Improvement of endothelium-dependent coronary vasodilation after a single LDL apheresis in patients with hypercholesterolemia. J Clin Apher. 2004;19(1):11-6. doi: 10.1002/jca.20000.

Reference Type BACKGROUND
PMID: 15095396 (View on PubMed)

Tamai O, Matsuoka H, Itabe H, Wada Y, Kohno K, Imaizumi T. Single LDL apheresis improves endothelium-dependent vasodilatation in hypercholesterolemic humans. Circulation. 1997 Jan 7;95(1):76-82. doi: 10.1161/01.cir.95.1.76.

Reference Type BACKGROUND
PMID: 8994420 (View on PubMed)

Kobayashi S, Moriya H, Maesato K, Okamoto K, Ohtake T. LDL-apheresis improves peripheral arterial occlusive disease with an implication for anti-inflammatory effects. J Clin Apher. 2005 Dec;20(4):239-43. doi: 10.1002/jca.20033.

Reference Type BACKGROUND
PMID: 15880405 (View on PubMed)

Moriarty PM, Gibson CA. Effect of low-density lipoprotein apheresis on lipoprotein-associated phospholipase A2. Am J Cardiol. 2005 May 15;95(10):1246-7. doi: 10.1016/j.amjcard.2005.01.058.

Reference Type BACKGROUND
PMID: 15878003 (View on PubMed)

Wang Y, Blessing F, Walli AK, Uberfuhr P, Fraunberger P, Seidel D. Effects of heparin-mediated extracorporeal low-density lipoprotein precipitation beyond lowering proatherogenic lipoproteins--reduction of circulating proinflammatory and procoagulatory markers. Atherosclerosis. 2004 Jul;175(1):145-50. doi: 10.1016/j.atherosclerosis.2004.03.011.

Reference Type BACKGROUND
PMID: 15186959 (View on PubMed)

Nakamura T, Matsuda T, Suzuki Y, Ueda Y, Koide H. Effects of low-density lipoprotein apheresis on plasma matrix metalloproteinase-9 and serum tissue inhibitor of metalloproteinase-1 levels in diabetic hemodialysis patients with arteriosclerosis obliterans. ASAIO J. 2003 Jul-Aug;49(4):430-4.

Reference Type BACKGROUND
PMID: 12918586 (View on PubMed)

Hovland A, Hardersen R, Sexton J, Mollnes TE, Lappegard KT. Different inflammatory responses induced by three LDL-lowering apheresis columns. J Clin Apher. 2009;24(6):247-53. doi: 10.1002/jca.20223.

Reference Type BACKGROUND
PMID: 19927364 (View on PubMed)

Kojima S, Shida M, Yokoyama H. Changes in C-reactive protein plasma levels during low-density lipoprotein apheresis. Ther Apher Dial. 2003 Aug;7(4):431-4. doi: 10.1046/j.1526-0968.2003.00080.x.

Reference Type BACKGROUND
PMID: 12887727 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

INFLAME_EUH

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00044778

Identifier Type: -

Identifier Source: org_study_id