Chronic Stable Angina, Refractory Angina
Conditions
Keywords
No-option patients
Brief summary
This study evaluates the addition of heparin to a 2-week cycle of physical rehabilitation in the treatment of refractory angina. Half of the patients will undergo heparin-primed physical rehabilitation, while the other half will undergo only physical rehabilitation.
Detailed description
Our approach is based on the combination of pharmacological stimuli (with heparin) on top of a 2-week cycle of physical rehabilitation. The rationale for this chemical-physical cocktail stems from the fact that increase in shear stress (achieved with exercise), or heparin (when used alone) have no significant effect on coronary arteriogenesis. Nevertheless, when the two stimuli are coupled coronary arteriogenesis is consistently present, and clinically significant. The basic principle of heparin treatment is to potentiates angiogenic growth factors, which are over expressed by increased shear stress at the site of pre-existing collateral vessels as a result of exercise or pacing. Although the precise mechanisms by which heparin potentiates arteriogenesis remain to be completely elucidated, heparin administration combined with exercise has great potential in treating patients with effort angina who are not indicated for conventional revascularization therapy.
Interventions
Standard treadmill exercise session
DRUGHeparin
Heparin i.v.
OTHERPlacebo
Sodium Chloride 0.9% i.v.
Sponsors
Fondazione C.N.R./Regione Toscana G. Monasterio, Pisa, Italy
Clinical Centre of Serbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, randomized, open-label study design. These no-option patients will be allocated (16 for each group) to 2 treatments
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients with documented coronary artery disease not amenable of future treatment and belonging to no-option category with symptoms consistent with angina pectoris
Exclusion criteria
* Patients with unstable angina, recent myocardial infarction, uncontrolled hypertension, hemodynamically valvular heart disease, bronchial asthma, and neurologic and/or orthopedic illnesses that limit exercise capacity . * Patients receiving vitamin K antagonist. * Patients actively involved in programmes of cardiac rehabilitation or exercise training.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline Canadian Cardiovascular Society (CCS) angina severity class at 2 weeks | 2 weeks | CCS class ranging from 1 (mild) to 4 (severe) before and after the 2-week physical rehabilitation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline peak stress wall motion score index (WMSI) at 2 weeks | 2 weeks | Peak WMSI at stress echocardiography before and after 2-week physical rehabilitation at . Wall motion score index is assessed by using 17- segment model of left ventricle (1=normal, 4=dyskinetic). |
| Change from baseline peak stress global longitudinal strain (GLS) at 2 weeks | 2 weeks | Peak stress GLS assessed by echocardiography before and after the 2-week physical rehabilitation. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline Coronary Collateral Circulation (CCC) at 2 weeks | 2 weeks | CCC score assessed by multi dimensional computed tomography (CT) before and after 2-week physical rehabilitation. Distal filling of the epicardial segment is semiquantitatively classified by using a four-point scale according to patterns at coronary CT angiography (CTA) (0 = absence of distal filling; 1 = partial distal filling, with a length less than one-third of the segment; 2 = partial distal filling, with a length between one-third and two-thirds of the segment; 3 = complete or partial distal filling, with a length longer than two-thirds of the segment). A coronary CTA scores correspond fully to Rentrop classification (coronary CTA score of 0 or 1 to Rentrop 0 or 1, coronary CTA score of 2 or 3 to Rentrop 2 or 3). Coronary CTA score of 3 is indicative of well-developed collaterals, contrary to scores of 0-2 (poorly developed). Also we look for change in growth of baseline bridging antegrade collaterals at 2 weeks (0= not present, 1= present) |
| Change from Baseline Stable Angina questionnaire (SAQ) at 4 weeks | 2 weeks to one month | 19-item Seattle SAQ that assesses angina frequency, angina stability, physical limitations, treatment satisfaction, and disease perception/QoL |
Countries
Serbia
Outcome results
None listed