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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00188188
Recruitment Status : Unknown
Verified March 2005 by University Health Network, Toronto.
Recruitment status was:  Recruiting
First Posted : September 16, 2005
Last Update Posted : December 29, 2005
Heart and Stroke Foundation of Canada
Information provided by:
University Health Network, Toronto

Brief Summary:
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 or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: quinipril Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Endothelial Dysfunction in Systemic Lupus Erythematosus: Its Contribution to Abnormalities in Coronary Perfusion.
Study Start Date : March 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00188188

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Contact: Anne Cymet, Rn 416-603-5800 ext 2895

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

Layout table for additonal information Identifier: NCT00188188     History of Changes
Other Study ID Numbers: SLED
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: December 29, 2005
Last Verified: March 2005

Keywords provided by University Health Network, Toronto:

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