Clinical trial NCT03350737: Coronary Arteriogenetic Heparinized Exercise
Official title: Coronary ARteriogenesis With Combined Heparin and EXercise Therapy in Chronic Refractory Angina
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractory Angina
Chronic Stable Angina
Keywords: No-option patients
Lead sponsor: Clinical Centre of Serbia
Sponsor class: OTHER
Collaborators: name: Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
First posted: 2017-11-22
Enrollment: 32
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, open-label study design. These "no-option" patients will be allocated (16 for each group) to 2 treatments
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline Canadian Cardiovascular Society (CCS) angina severity class at 2 weeks
timeFrame: 2 weeks
Secondary outcomes:
measure: Change from Baseline peak stress wall motion score index (WMSI) at 2 weeks
timeFrame: 2 weeks
measure: Change from baseline peak stress global longitudinal strain (GLS) at 2 weeks
timeFrame: 2 weeks
Other outcomes:
measure: Change from Baseline Coronary Collateral Circulation (CCC) at 2 weeks
timeFrame: 2 weeks
measure: Change from Baseline Stable Angina questionnaire (SAQ) at 4 weeks
timeFrame: 2 weeks to one month
Locations:
city: Belgrade
country: Serbia
facility: Clinical Centre of Serbia
Study officials:
affiliation: Clinical Centre of Serbia
name: Branko Beleslin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Centre of Serbia
name: Ana Djordjevic-Dikic, MD, PhD
role: STUDY_DIRECTOR
affiliation: Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
name: Eugenio Picano, MD, PhD
role: STUDY_CHAIR
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