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Lipoprotein Apheresis in Refractory Angina Study

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ClinicalTrials.gov Identifier: NCT01796912
Recruitment Status : Completed
First Posted : February 22, 2013
Results First Posted : November 12, 2019
Last Update Posted : November 12, 2019
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
Imperial College London

Study Description
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Brief Summary:
The goal of this study is to determine the impact of apheresis on clinical parameters and symptoms of patients with refractory angina and raised Lp(a). The investigators will conduct a prospective, randomised controlled crossover study of 20 patients with refractory angina and raised Lp(a), randomised to undergoing lipoprotein apheresis weekly for three months or sham apheresis weekly for three months with assessment of myocardial perfusion, carotid atherosclerosis, endothelial vascular function, thrombogenesis, exercise capacity, angina symptoms and quality of life at the beginning and end of treatment. Patients will then crossover to the opposite study arm with the protocol repeated. The hypothesis is that the above parameters will be improved by lipoprotein apheresis in patients with raised Lp(a) and Refractory Angina. Investigators will also test for the genotypic presence of apolipoprotein(a) gene (LPA) locus variants (rs10455872 and rs3798220) which are thought to be associated with an increased level of Lp(a) and an increased risk of coronary disease.

Condition or disease Intervention/treatment Phase
Refractory Angina Raised Lipoprotein(a)>50mg/dL or >500mg/L Other: Lipoprotein Apheresis Other: Sham Apheresis Not Applicable

Detailed Description:
Angina which is refractory to conventional medical therapy and revascularisation is challenging to manage. Lipoprotein(a) or Lp(a) is a genetically determined form of LDL-cholesterol, elevation of which is an independent risk factor and predictor of adverse cardiovascular events. Lp(a) is felt to increase cardiovascular risk via its prothrombotic effect and by enhancing intimal lipoprotein deposition. Lipoprotein apheresis is the most effective treatment for raised Lp(a). Lipid lowering agents such as statins have little to no effect on Lp(a) levels.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Clinical Outcomes, Perfusion and Vascular Function in Patients With Refractory Angina and Raised Lipoprotein (a), Treated With Lipoprotein Apheresis
Actual Study Start Date : February 2013
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: First Lipoprotein Apheresis, then sham apheresis
Three months of weekly lipoprotein apheresis, 1 month washout, then three month sham apheresis
 Other: Lipoprotein Apheresis
Weekly lipoprotein apheresis for 3 months
Sham Comparator: First Sham Apheresis, then Lipoprotein Apheresis
Three months of weekly sham apheresis, 1 month washout, then three month lipoprotein Apheresis
 Other: Sham Apheresis
Weekly sham (placebo) apheresis for 3 months


Outcome Measures
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Primary Outcome Measures :
  1. Changes in Quantitative Myocardial Perfusion Measured by Stress/Rest Cardiovascular Magnetic Resonance Imaging [ Time Frame: 3 months ]

    Baseline compare to 3 month, changes presented Determine the impact of lipoprotein apheresis on quantitative myocardial perfusion measured by stress/rest cardiovascular magnetic resonance imaging.

    Increase means better outcome



Secondary Outcome Measures :
  1. Change in Carotid Atherosclerosis/Plaque Burden Determined by Cardiovascular Magnetic Resonance Imaging [ Time Frame: 3 months ]
    Changes from baseline to 3 months

  2. Change in Endothelial Vascular Function [ Time Frame: Within 7 days before and after 3 months of weekly lipoprotein apheresis ]
    EndoPat LnRHI - natural logarithm of reactive hyperaemia index. Increase - better outcome

  3. Change in Seattle Angina Questionnaire Score [ Time Frame: 3 months ]
    SAQ-Angina stability, increase means improvement. 0-100 scale, Higher score means improvements

  4. Change in SF-36 Quality of Life Score [ Time Frame: 3 months ]
    Quality of Life score following, 0-100 score, high score improve quality of life

  5. Change in Exercise Capacity Determined by Six Minute Walk Test [ Time Frame: 3 months ]
    Six minute walk test, patient can walk longer distance means improvements

  6. Changes in Markers of Thrombogenesis [ Time Frame: 3 months ]
    Thrombogenesis, Reduce value is better to the patients


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients diagnosed with refractory angina for more than three months.
  • Two or more episodes of angina per week.
  • Previous history of myocardial infarction, coronary artery bypass graft (CABG) surgery,percutaneous coronary intervention (PCI) or any combination of the above.
  • Prescribed optimal medical therapy.
  • Hypercholesterolaemia with an elevated Lp(a) > 50mg/dL and an LDL-cholesterol less than 4.0mmol/L despite optimal lipid lowering drug therapy.

Exclusion Criteria:

  • Patients with poor calibre veins for cannulation.
  • Patients with any other chronic systemic illness such as liver or renal failure, neoplastic disease, overt cardiac failure, unstable coronary artery disease, coronary revascularisation or a myocardial infarction within the previous eight weeks.
  • Pregnancy, untreated diabetes mellitus, untreated arterial hypertension, and those with general contraindications to undergoing Cardiovascular magnetic resonance imaging or contraindications to adenosine.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01796912


Locations
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United Kingdom
Royal Brompton and Harefield NHS Foundation Trust
London, United Kingdom
Sponsors and Collaborators
Imperial College London
National Institute for Health Research, United Kingdom
Investigators
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Principal Investigator: Dudley Pennell, MB BChir MA MD FRCP Imperial College London
Study Director: Mahmoud Barbir, MB BCh, FRCP Royal Brompton and Harfield Hospital, Imperial College
More Information
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Publications of Results:

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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01796912    
Other Study ID Numbers: 1880
First Posted: February 22, 2013    Key Record Dates
Results First Posted: November 12, 2019
Last Update Posted: November 12, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imperial College London:
Refractory Angina
Lipoprotein
Additional relevant MeSH terms:
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Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
 Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations