NCT01138371

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 7, 2010

Completed
9 months until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

December 17, 2013

Status Verified

December 1, 2013

Enrollment Period

11 months

First QC Date

June 4, 2010

Last Update Submit

December 16, 2013

Conditions

Familial Hypercholesterolemia

Keywords

LDL apheresisFamilial hypercholesterolemiaInflammatory markersHyperlipidemiaCardiovascular disease

Outcome Measures

Primary Outcomes (2)

  • Lipid Marker Change

    We will measure the level of cholesterol markers in your blood before and after the LDL apheresis procedure with a blood draw.

    1 month

  • Inflammatory Marker Change

    We will measure the level of inflammatory markers in your blood before and after the LDL apheresis procedure with blood draws (for 2 apheresis sessions)

    1 month

Secondary Outcomes (1)

  • Inflammatory Marker Rebound

    2 days

Study Arms (1)

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

Procedure: LDL Apheresis

Interventions

LDL ApheresisPROCEDURE

LDL Apheresis

Also known as: Apheresis, LDL filtration
Familial hypercholesterolemia

Eligibility Criteria

Age3 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This study focuses on people who are currently on stable LDL apheresis treatment for high cholesterol.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Related Publications (14)

  • 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.

    PMID: 9141382BACKGROUND

  • 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.

    PMID: 19627661BACKGROUND

  • 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.

    PMID: 15172629BACKGROUND

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

    PMID: 12618263BACKGROUND

  • 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.

    PMID: 7898227BACKGROUND

  • 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.

    PMID: 8635262BACKGROUND

  • 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.

    PMID: 15095396BACKGROUND

  • 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.

    PMID: 8994420BACKGROUND

  • 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.

    PMID: 15880405BACKGROUND

  • 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.

    PMID: 15878003BACKGROUND

  • 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.

    PMID: 15186959BACKGROUND

  • 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.

    PMID: 12918586BACKGROUND

  • 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.

    PMID: 19927364BACKGROUND

  • 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.

    PMID: 12887727BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples only

MeSH Terms

Conditions

Hyperlipoproteinemia Type IIHyperlipidemiasCardiovascular Diseases

Interventions

Blood Component Removal

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperlipoproteinemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Laurence Sperling, MD

    Emory University

    PRINCIPAL INVESTIGATOR

  • Vimal Ramjee, MD

    Emory University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2010

First Posted

June 7, 2010

Study Start

March 1, 2011

Primary Completion

February 1, 2012

Study Completion

March 1, 2012

Last Updated

December 17, 2013

Record last verified: 2013-12

Locations

US(1)