EUCTR2012-000196-17-GBActive, not recruitingNot Applicable
The Effects of Inorganic Nitrite on cardiac and skeletal muscle: Physiology, pharmacology and therapeutic potential in patients suffering from Angina - Effects of Inorganic Nitrite on cardiac and skeletal muscle: Angina
Not provided0 sitesStarted: March 21, 2012Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Patients with chronic stable angina (>2 months duration) who are on no background antianginal therapy other than short acting nitrates will be recruited. Entry criteria comprise a positive exercise ECG (>2mm ST segment depression at the J2 point) at 3-9 mins on a modified Bruce protocol treadmill exercise test and a positive dobutamine stress echocardiogram.
- •This should now be:
- •Patients aged 18 and over with chronic stable angina (>=2 months duration). Patients can be on background anti-anginal therapy, however this dose of the background treatment has to ideally remain fixed during the trial. Entry criteria comprise a positive exercise ECG (>=1mm ST segment depression at the J point) within 9 mins on a modified Bruce protocol treadmill exercise test and either a positive dobutamine stress echocardiogram and/or a positive myocardial perfusion scan (MPI) and/or a positive coronary angiogram. Patients who meet these entry criteria but who have not had a 'clinical' dobutamine stress echocardiogram may also be asked to undergo a screening dobutamine stress echocardiogram (DSE). Those patients who have a positive DSE will be asked to have two further DSE's (one at the end of each limb of the study), which is a predefined secondary endpoint assessment.
- •This should now be:
- •Patients aged 18 and over with chronic stable angina (>=2 months duration). Patients can be on background anti-anginal therapy, however this dose of the background treatment has to ideally remain fixed during the trial. Entry criteria comprise a positive exercise ECG (>=1mm ST segment depression at the J point) on a modified Bruce protocol treadmill exercise test and either a positive dobutamine stress echocardiogram and/or a positive myocardial perfusion scan (MPI) and/or a positive coronary angiogram. Patients who meet these entry criteria but who have not had a 'clinical' dobutamine stress echocardiogram may also be asked to undergo a screening dobutamine stress echocardiogram (DSE). Those patients who have a positive DSE will be asked to have two further DSE's (one at the end of each limb of the study), which is a predefined secondary endpoint assessment.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 0
Exclusion Criteria
- •Patients that are taking Calcium-channel blockers, Ivabradine, Nicorandil and long acting nitrates will be excluded. Women of child bearing age will be excluded from the study.
- •This should now be:
- •* Unable to do exercise test
- •* Women of child bearing potential
- •* If of a racial origin at risk of G6PD deficiency, G6PD will be excluded prior to inclusion in the study
- •* Resting STD>=1mm
- •* NYHA 3 or 4 HF or LVEF<45%
- •* Myocardial infarction or revascularisation within the last two months
Investigators
Similar Trials
Active, not recruiting
Phase 1
The Effects of Inorganic Nitrite on cardiac and skeletal muscle: Physiology, Pharmacology and Therapeutic Potential in patients suffering from chronic heart failure.Chronic heart failureEUCTR2012-000788-26-GB56
Active, not recruiting
Phase 1
The Effects of Inorganic Nitrite on skeletal muscle: Physiology, Pharmacology and Therapeutic Potential in patients suffering from Intermittent Claudication.Peripheral arterial DiseaseEUCTR2012-000201-72-GBniversity of Aberdeen132
Completed
Not Applicable
The effect of inorganic nitrite on endothelial function in ischaemia-reperfusion in the human forearmCardiovascularCirculatory SystemISRCTN57823880Record Provided by the NHSTCT Register - 2006 Update - Department of Health (UK)10
Completed
Phase 2
The Effects of Inorganic Nitrate on Cardiac Muscle in AnginaChronic Stable AnginaNCT02078921University of Aberdeen70
Unknown
Phase 2
Nitrite Effects on Cardiac Muscle in CABGVascular DiseasesAtherosclerosisCoronary Artery DiseaseCardiac DiseaseDiabetes MellitusNCT04001283University of East Anglia75