Lipoprotein Apheresis in Refractory Angina Study

This study is currently recruiting participants.
Verified February 2013 by Imperial College London
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01796912
First received: February 15, 2013
Last updated: February 20, 2013
Last verified: February 2013

February 15, 2013
February 20, 2013
February 2013
August 2015   (final data collection date for primary outcome measure)
Change in Quantitative myocardial perfusion measured by stress/rest cardiovascular magnetic resonance imaging following 3 months weekly apheresis compared to baseline. [ Time Frame: Within 7 days before and after three months of weekly apheresis ] [ Designated as safety issue: No ]
Investigators will determine the impact of lipoprotein apheresis on quantitative myocardial perfusion measured by stress/rest cardiovascular magnetic resonance imaging at baseline and after 3 months of weekly lipoprotein apheresis in patients with refractory angina and raised lipoprotein(a). This will be compared to quantitative perfusion before and after 3 months of sham apheresis.
Same as current
Complete list of historical versions of study NCT01796912 on ClinicalTrials.gov Archive Site
  • Change in Carotid Atherosclerosis/plaque burden determined by Cardiovascular Magnetic Resonance Imaging following 3 months weekly apheresis compared to baseline. [ Time Frame: Within 7 days before and after 3 months of weekly lipoprotein apheresis ] [ Designated as safety issue: No ]
  • Change in Endothelial vascular function following 3 months weekly apheresis compared to baseline. [ Time Frame: Within 7 days before and after 3 months of weekly lipoprotein apheresis ] [ Designated as safety issue: No ]
  • Change in Seattle Angina Questionnaire Score following 3 months weekly apheresis compared to baseline. [ Time Frame: Within 7 days before and after 3 months of weekly lipoprotein apheresis ] [ Designated as safety issue: No ]
  • Change in SF-36 Quality of Life score following 3 months weekly apheresis compared to baseline. [ Time Frame: Within 7 days before and after 3 months of weekly lipoprotein apheresis ] [ Designated as safety issue: No ]
  • Change in Exercise capacity determined by six minute walk test following 3 months weekly apheresis compared to baseline. [ Time Frame: Within 7 days before and after 3 months of weekly lipoprotein apheresis ] [ Designated as safety issue: No ]
  • Changes in Markers of Thrombogenesis following 3 months weekly apheresis compared to baseline. [ Time Frame: Within 24 hours before and after 3 months of weekly lipoprotein apheresis ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Lipoprotein Apheresis in Refractory Angina Study
Clinical Outcomes, Perfusion and Vascular Function in Patients With Refractory Angina and Raised Lipoprotein (a), Treated With Lipoprotein Apheresis

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.

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 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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Refractory Angina
  • Raised Lipoprotein(a)>50mg/dL or >500mg/L
  • Other: Lipoprotein Apheresis
  • Other: Sham Apheresis
  • Active Comparator: Lipoprotein Apheresis
    Three months of weekly lipoprotein apheresis
    Intervention: Other: Lipoprotein Apheresis
  • Sham Comparator: Sham Apheresis
    Three months of weekly sham apheresis
    Intervention: Other: Sham Apheresis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
January 2016
August 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact: Mahmoud Barbir, MB BCh BAO LRCP&SI FRCP 07767823790 M.Barbir@rbht.nhs.uk
United Kingdom
 
NCT01796912
1880
Yes
Imperial College London
Imperial College London
National Institute for Health Research, United Kingdom
Principal Investigator: Dudley Pennell, MB BChir MA MD FRCP FACC FESC Imperial College London
Study Director: Mahmoud Barbir, MB BCh BAO LRCP&SI FRCP Royal Brompton and Harfield Hospital, Imperial College
Imperial College London
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP