An interventional study of Physical rehabilitation and Heparin in Refractory Angina and Chronic Stable Angina, sponsored by Clinical Centre of Serbia. Completed at 1 site in Serbia. Per ClinicalTrials.gov, last updated 2020-05-13.
Sponsored by Clinical Centre of Serbia · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
2 exercise sessions per day for 5 days a week for 2 weeks with 100 IU/kg of Heparin i.v. (up to a maximum of 5000 IU) 10 minutes prior to exercise
Other: Physical rehabilitation · Drug: Heparin
2 exercise sessions per day for 5 days a week for 2 weeks with placebo (2 ml of Sodium Chloride 0.9% i.v.) 10 minutes prior to exercise
Other: Physical rehabilitation · Other: Placebo
Standard treadmill exercise session
Also known as: E
Heparin i.v.
Also known as: H
Sodium Chloride 0.9% i.v.
Also known as: P
Change from Baseline Canadian Cardiovascular Society (CCS) angina severity class at 2 weeks
CCS class ranging from 1 (mild) to 4 (severe) before and after the 2-week physical rehabilitation.
Time frame: 2 weeks
Change from Baseline peak stress wall motion score index (WMSI) at 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).
Time frame: 2 weeks
Change from baseline peak stress global longitudinal strain (GLS) at 2 weeks
Peak stress GLS assessed by echocardiography before and after the 2-week physical rehabilitation.
Time frame: 2 weeks
Change from Baseline Coronary Collateral Circulation (CCC) at 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)
Time frame: 2 weeks
Change from Baseline Stable Angina questionnaire (SAQ) at 4 weeks
19-item Seattle SAQ that assesses angina frequency, angina stability, physical limitations, treatment satisfaction, and disease perception/QoL
Time frame: 2 weeks to one month
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — De-identified individual participant data for all primary and secondary outcome measures will be made available.
Supporting information: Study protocol, Sap
This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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Clinical Centre of Serbia