Patients with cardiac syndrome X (typical anginal-like chest pain and normal coronary arteriograms)
Conditions
Interventions
Trade Name: There is no trade name for Allopurinol
Product Name: Allopurinol
Pharmaceutical Form: Capsule*
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Sponsors
University of Dundee
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Criteria of inclusion as patients with cardiac syndrome X are as follows: 1.Typical chest pain at rest and/or on effort; normal 12-lead ECG at rest 2.Ischaemia-like ECG changes during exercise stress test (horizontal or downsloping ST-segment depression >0.1 mV) and/or myocardial reversible perfusion abnormalities during exercise stress as assessed by Technetium-99m stress myocardial perfusion imaging. 3 Normal left and right ventricular function at rest as assessed by echocardiography; absence of valvular heart disease and myocardial hypertrophy, and 4.Normal coronary angiograms at visual analysis. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Age75 yrs); 2.Patients with a history of poorly controlled hypertension. 3.Patients with a history of hypersensitivity reaction as a result of allopurinol. 4.Renal dysfunction (serum creatinine > 160 mmol/L) or anaemia (haemoglobin 190 mmHg at rest or >250 mmHg with exercise or diastolic blood pressure >95 mmHg at rest or >105 mmHg with exercise will also be a reason for exclusion. 7.Patients with underlying disease likely to limit life span and/or increase risk of interventions will be excluded i.e., cancer; cardiovascular disease; uncontrolled hypertension: SBP>180 mmHg or DBP>110 mmHg, recent stroke, any severe chronic disease (including renal and hepatic disease). 8.Pregnancy and lactating women. 9.Patient on azathioprine therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to investigate the effects of allopurinol on coronary and peripheral microvascular and endothelial function in patients with cardiac syndrome X. ;Secondary Objective: The secondary objectives of this study are to assess the effects of allopurinol on chest pain incidence, maximal ST-segment depression, Duke score and biochemical markers.;Primary end point(s): 1. Coronary mircovascular function: Coronary flow reserve of the left anterior descending artery using doppler echocardiography. 2. Peripheral Microvascular function: Changes in microvascular skin blood flow using laser Doppler imaging. 3. Peripheral endothelial function: Flow-mediated vasodilation of brachial artery using duplex ulrasound imaging. | — |
Countries
United Kingdom
Outcome results
None listed