A study to compare spinal cord stimulator implantation with laser treatment of the heart in patients with chronic angina
- Conditions
- Chronic angina pectorisAngina pectorisCirculatory System
- Registration Number
- ISRCTN09648950
- Lead Sponsor
- Medtronic Sàrl (Switzerland)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 68
1. Patient with limiting angina (Canadian Cardiovascular Society [CCS] III or IV) despite maximally tolerated medical therapy
2. Documented coronary artery disease (within the last 9 months prior to baseline), which is
unsuitable for conventional revascularisation techniques
3. Patient has documented reversible ischaemia on nuclear scan (Tc-99 sestamibi)
4. Patient is limited in daily activities, primarily exercise capability, by their anginal pain
5. Age 18 or older
6. Patient must understand the therapy and give informed consent
7. Patient must be available for appropriate follow-up times for length of study
8. Non-pregnant women (only women who are post menopausal, surgically sterile or those of
child bearing potential who are using an acceptable method of contraception) as safety for
use of SCS during pregnancy or delivery has not been established. Acceptable methods of
contraception include the following:
a. Barrier type devices (e.g. female condom, diaphragm and contraceptive sponge) used only in combination with a spermicide
b. Intrauterine devices (IDUs)
c. Oral contraceptive agent
d. Depro-ProveraTM (medroxyprogesterone acetate)
e. Levonorgestrel implants
f. Naturally sterile (amenorrheic for at least 1 year) in patients over 50
Note: Abstinence, the rhythm method or contraception by the partner alone are NOT acceptable methods of contraception
1. Patient who is not a candidate for surgical implantation of the spinal cord stimulation system,
and/or not a candidate for a PMR procedure and/or unable to use the SCS device appropriately for treatment
2. Patient who has had one or more major cardiac events within the last 2 months
3. Patient with a myocardial wall thickness <8 mm in the ischaemic area to be treated as verified
by echocardiography
4. Patient with extensive peripheral vascular disease that precludes vascular access required for
PMR
5. Patient on intravenous therapy to control their symptoms
6. Patient who is unlikely to survive for more than 12 months due to non cardiac condition e.g.
malignancy
7. Patient who has other diseases that are considered of greater clinical significance than the
angina pectoris (e.g. inadequately controlled diabetes mellitus, heart failure) that would impact
the ability of the clinician to adequately assess the incremental effects of the trial treatment
8. Patient with ejection fraction of less than 30% as verified by echocardiography
9. Patient with cause of angina other than coronary artery disease (e.g. syndrome X patient)
10. Patient who is unable to perform treadmill exercise test per protocol
11. Patient who was previously enrolled in this study, or is currently in another clinical study, which will interfere with this protocol
12. Patient who has had spinal cord stimulation (SCS) therapy, a transmyocardial laser revascularization (TMLR) or PMR procedure in the past
13. Patient with an implanted pacemaker or defibrillator
14. Patient who has medical conditions which may require Magnetic Resonance Imaging (MRI)
15. Patient with a history of dementia or other persisting mental disorders significantly interfering
with ability to cooperate or comply with the requirements of the study or comprehend informed
consent
16. Patient with history of alcohol or drug abuse
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Total exercise time on a modified Bruce protocol (ETT) at 12 months after SCS compared with PMR. In this study, all tests were terminated by the subject. Both SCS and PMR aim to reduce the frequency and severity of angina, and exercise tolerance is a comparatively objective method of measuring angina-free functional capacity.
- Secondary Outcome Measures
Name Time Method 1. Time to patient-reported angina during exercise test<br>2. Angina class as measured by the Canadian Cardiovascular Score angina scale<br>3. Morbidity and mortality<br>4. Safety profiles of each therapy<br>5. Health-related quality of life was assessed using questionnaires administered at 3, 12, 24 and 36 month follow-up (disease-specific Seattle Angina Questionnaire, the generic Short Form 36 health survey , and EuroQoL questionnaires)