Study of Endothelial Dysfunction in Systemic Lupus and Its Role in Heart Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2005 by University Health Network, Toronto.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Heart and Stroke Foundation of Canada
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00188188
First received: September 9, 2005
Last updated: December 28, 2005
Last verified: March 2005
  Purpose

Systemic Lupus Erythematosus is a relatively common autoimmune disease that affects mainly women.Cardiovascular disease as a result of accelerated atherosclerosis is a major cause of mortality and morbidity in SLE.Previous research has shown that 35-40% of patients with SLE have abnormalities of myocardial perfusion even when they have no coronary stenoses on coronary angiography. The reason for these frequent perfusion abnormalities in the absence of angiographically significant CAD remains uncertain, but could conceivably result from endothelial dysfunction. In SLE, coronary endothelial dysfunction could result from the inflammatory process involved in the SLE disease itself, a finding that could explain the correlation between disease activity and the development of CAD in these patients.As such endothelial dysfunction may account for accelerated atherosclerosis and cardiac perfusion defects (without angiographically significant coronary lesions). We propose to first evaluate whether endothelial dysfunction occurs in these patients and is more frequent in patients with myocardial perfusion abnormalities. Endothelial function will be assessed by measuring flow-mediated brachial artery dilatation. In the 250 patients included in the study we will correlate endothelial function and myocardial perfusion abnormalities to SLE disease activity, to its treatment and to the presence of CAD risk factors In a subgroup of patients (estimated 5 patients) in whom it is clinically indicated, coronary angiography will be performed in order to assess the presence of significant coronary stenoses (>50%),coronary artery reserve and coronary endothelial dysfunction. We will then attempt to reverse abnormalities in endothelial function and myocardial perfusion by therapy with an ACE inhibitor(Quinapril).Patients with myocardial perfusion abnormalities will be randomised to receive Medication A(oral Quinapril or Placebo) for 8 weeks, will have all baseline investigations repeated and then will switch over and receive medication B(Quinapril or placebo) for a further 8 weeks followed by repeat investigations.


Condition Intervention Phase
Systemic Lupus Erythematosus
Drug: quinipril
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Endothelial Dysfunction in Systemic Lupus Erythematosus: Its Contribution to Abnormalities in Coronary Perfusion.

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Estimated Enrollment: 50
Study Start Date: March 2002
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

>20 years Lupus according to ACR criteria Patients who demonstrate abnormality on mycardial perfusion imaging are eligible for treatment arm of study

-

Exclusion Criteria:

Steroid dependent asthma known contraindication to dipyridamole known intolerance to or contraindication to use of ACE inhibitors history of angioedema serum creatinine. 200mmol/l Renal artery stenosis pregnant or breast feeding inability to perform low grade exercise presently taking ACE, ARB or nitrates

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00188188

Contacts
Contact: Anne Cymet, Rn 416-603-5800 ext 2895 anne.cymet@uhn.on.ca

Locations
Canada, Ontario
University Health Network, Toronto Western Division Recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Anne Cymet, RN    416-603-5800 ext 2895    anne.cymet@uhn.on.ca   
Principal Investigator: Robert M Iwanochko, MD, FRCP(C), FACC         
Sponsors and Collaborators
University Health Network, Toronto
Heart and Stroke Foundation of Canada
Investigators
Study Director: Robert M Iwanochko, MD University Health Network, Toronto
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00188188     History of Changes
Other Study ID Numbers: SLED
Study First Received: September 9, 2005
Last Updated: December 28, 2005
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
Endothelial
Dysfunction
Systemic
Lupus

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 26, 2014