Peripheral Arterial Disease: Intermittent Claudication MedDRA version: 14.1 Level: LLT Classification code 10009241 Term: Claudication intermittent System Organ Class: 100000004866
Conditions
Interventions
Trade Name: Ramipril 2.5mg
Product Name: Ramipril 2.5mg
Pharmaceutical Form: Tablet
Trade Name: Ramipril 5mg
Pharmaceutical Form:
Trade Name: Ramipril 5mg
Pharmaceutical Form:
Pharmaceutical form
Sponsors
Hull and East Yorkshire Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Patients listed for elective femoropopliteal PTA for intermittant claudication due to peripheral artery disease -Patients with unilateral or bilateral intermittent leg claudication which was stable for the last 6 months. -Patients with ABPI =65 years) yes F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: Documented bilateral renal artery stenosis Diabetes Mellitus types 1 or 2 Unlikely to be compliant with medication or follow up as determined by the recruiting institution. Patients who had a recent (less than 3 months) angioplasty or bypass surgery Pregnancy and breast feeding Patients with critical limb ischemia (This includes patients with ischaemic rest pain and ulceration > 2 weeks and/or a resting ankle pressure 30% from baseline and/or Potassium > 5.9 mmol/l Unwillingness to participate. Level 1 evidence for ACE inhibitor treatment, including: a) Documented heart failure, left ventricular dysfunction or ejection fraction 160mmHg systolic or 100mmHg diastolic on 3 separate readings measured after 10 minutes rest on 2 separate occasions c) Recent ( 250 micromol/l)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The principal research objective of this trial is to assess whether the combination of ramipril with Percutaneous Transluminal Angioplasty (PTA) improves maximum walking distance, when compared to PTA alone, in sufferers of Intermittent Claudication (IC). IC is exercise pain due to arterial disease causing impaired blood supply to the muscles. Primary outcome measure for this trial is the Maximum Walking Distance (MWD). Treadmill exercise test will be used to estimate the maximum distance the participant can walk at a speed of 2.5 km/h with a 10 degree incline for a maximum of 15 minutes. This time will be recorded in both placebo and ramipril groups at baseline and at 6 and 24 weeks.;Secondary Objective: Secondary Outcome Measures: 1. Other clinical indicators of lower limb ischaemia: a) Patient Reported Walking Distance (PRWD)- This is a distance, in metres, that the patient estimates that they can walk. b) Treadmill Intermittent Claudication Distance (ICD) or the distance associated with the onset of claudication pain measured on the same standardised treadmill test c) Ankle Brachial Pressure Index (ABPI) at rest and following treadmill testing. ABPI is a comparison of pressure in the peripheral arteries of the foot and ankle compared to the blood pressure in their arm as we would routinely measure it. This is a standard diagnostic marker of Peripheral Arterial Disease. d) Progression of disease: we will monitor how many patients go on to develop worsening disease. This may be indicated by rest pain, gangrene or acute ischaemia. In intermittent Claudication sufferers will experience pain on exertion. With rest pain, the disease is so severe that the pain persists even when t;Primary end point(s): The primary outcome measure is Maximal Walking Distance (MWD). This will be measured on a treadmill exercise test, lasting 15 minutes, with a walking speed of 2.5km/hr with a 10 degree incline.;Timepoint(s) of evaluation of this end point: Measures will | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Outcome Measures: 1. Other clinical indicators of lower limb ischaemia: a) Patient Reported Walking Distance (PRWD)- This is a distance, in metres, that the patient estimates that they can walk. b) Treadmill Intermittent Claudication Distance (ICD) or the distance associated with the onset of claudication pain measured on the same standardised treadmill test c) Ankle Brachial Pressure Index (ABPI) at rest and following treadmill testing. ABPI is a comparison of pressure in the peripheral arteries of the foot and ankle compared to the blood pressure in their arm as we would routinely measure it. This is a standard diagnostic marker of Peripheral Arterial Disease. d) Progression of disease: we will monitor how many patients go on to develop worsening disease. This may be indicated by rest pain, gangrene or acute ischaemia. In intermittent Claudication sufferers will experience pain on exertion. With rest pain, the disease is so severe that the pain persists even when the individual is not exercising. Gangrene occurs when the blood supply is so poor that there is dead tissue (skin or muscle). Acute ischaemia is when there is a sudden blockage of an artery. This is considered an emergency and can lead to amputation if the blood supply is not restored. 2. Quality of life: This will be assessed using several validated questionnaires. We will look at generic and disease specific quality of life. a) Generic – measured using the SF36V2, SF6D and EuroQol (EQ5D) instruments b) Disease specific – measured using the VascuQol 3. Cardiovascular prognosis (risk of heart attacks and strokes and other vascular events) will be assessed using validated scoring systems. These will include Framingham, PROCAM, QRISK and Manchester charts scoring systems. We will also look at certain biochemical and haematological markers in the blood that have been linked with altered cardiovascular risk including - B-type Natriuretic Peptide (BNP) and N- terminal proho | — |
Countries
United Kingdom
Outcome results
None listed