Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00188188
Status:
UNKNOWN
Last Update Posted:
2005-12-29
First Post:
2005-09-09
Brief Title:
Study of Endothelial Dysfunction in Systemic Lupus and Its Role in Heart Disease
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Endothelial Dysfunction in Systemic Lupus Erythematosus Its Contribution to Abnormalities in Coronary Perfusion
Status:
UNKNOWN
Status Verified Date:
2005-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Systemic Lupus Erythematosus is a relatively common autoimmune disease that affects mainly womenCardiovascular disease as a result of accelerated atherosclerosis is a major cause of mortality and morbidity in SLEPrevious 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 patientsAs 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 50coronary artery reserve and coronary endothelial dysfunction We will then attempt to reverse abnormalities in endothelial function and myocardial perfusion by therapy with an ACE inhibitorQuinaprilPatients with myocardial perfusion abnormalities will be randomised to receive Medication Aoral Quinapril or Placebo for 8 weeks will have all baseline investigations repeated and then will switch over and receive medication BQuinapril or placebo for a further 8 weeks followed by repeat investigations
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None