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Trial record 64 of 176 for:    Recruiting, Not yet recruiting, Available Studies | Chest pain

Coronary Arteriogenetic Heparinized Exercise (CARHEXA)

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ClinicalTrials.gov Identifier: NCT03350737
Recruitment Status : Recruiting
First Posted : November 22, 2017
Last Update Posted : February 4, 2019
Sponsor:
Collaborator:
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
Information provided by (Responsible Party):
Branko Beleslin, Clinical Centre of Serbia

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.

Condition or disease Intervention/treatment Phase
Refractory Angina Chronic Stable Angina Other: Physical rehabilitation Drug: Heparin Other: Placebo Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, randomized, open-label study design. These "no-option" patients will be allocated (30 for each group) to 2 treatments
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Coronary ARteriogenesis With Combined Heparin and EXercise Therapy in Chronic Refractory Angina
Actual Study Start Date : February 1, 2013
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Heparin-primed physical rehabilitation
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
Standard treadmill exercise session
Other Name: E

Drug: Heparin
Heparin i.v.
Other Name: H

Placebo Comparator: Placebo-primed physical rehabilitation
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
Standard treadmill exercise session
Other Name: E

Other: Placebo
Sodium Chloride 0.9% i.v.
Other Name: P




Primary Outcome Measures :
  1. Change from Baseline Canadian Cardiovascular Society (CCS) angina severity class at 2 weeks [ Time Frame: 2 weeks ]
    CCS class ranging from 1 (mild) to 4 (severe) before and after the 2-week physical rehabilitation.


Secondary Outcome Measures :
  1. Change from Baseline peak stress wall motion score index (WMSI) at 2 weeks [ Time Frame: 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).

  2. Change from baseline peak stress global longitudinal strain (GLS) at 2 weeks [ Time Frame: 2 weeks ]
    Peak stress GLS assessed by echocardiography before and after the 2-week physical rehabilitation.


Other Outcome Measures:
  1. Change from Baseline Coronary Collateral Circulation (CCC) at 2 weeks [ Time Frame: 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)

  2. Change from Baseline Stable Angina questionnaire (SAQ) at 4 weeks [ Time Frame: 2 weeks to one month ]
    19-item Seattle SAQ that assesses angina frequency, angina stability, physical limitations, treatment satisfaction, and disease perception/QoL



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03350737


Contacts
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Contact: Branko Beleslin, MD, PhD +381638328690 branko.beleslin@gmail.com
Contact: Marija Petrovic, MD +381641144044 petrovic_marija@yahoo.com

Locations
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Serbia
Clinical Centre of Serbia Recruiting
Belgrade, Serbia, 11000
Contact: Marija Petrovic, MD    +381641144044    petrovic_marija@yahoo.com   
Contact: Vojislav Giga, MD, PhD    +381638074870    voja2011@yahoo.com   
Principal Investigator: Branko Beleslin, MD, PhD         
Sub-Investigator: Ana Djordjevic-Dikic, MD, PhD         
Sub-Investigator: Vojislav Giga, MD, PhD         
Sub-Investigator: Marija Petrovic, MD         
Sponsors and Collaborators
Clinical Centre of Serbia
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
Investigators
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Principal Investigator: Branko Beleslin, MD, PhD Clinical Centre of Serbia
Study Director: Ana Djordjevic-Dikic, MD, PhD Clinical Centre of Serbia
Study Chair: Eugenio Picano, MD, PhD Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
  Study Documents (Full-Text)

Documents provided by Branko Beleslin, Clinical Centre of Serbia:

Publications:

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Responsible Party: Branko Beleslin, Clinical research, Clinical Centre of Serbia
ClinicalTrials.gov Identifier: NCT03350737     History of Changes
Other Study ID Numbers: 128/8
First Posted: November 22, 2017    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: After the study completion.
Access Criteria: For collaborators, data analyses upon request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Branko Beleslin, Clinical Centre of Serbia:
No-option patients
Additional relevant MeSH terms:
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Chest Pain
Pain
Angina Pectoris
Angina, Stable
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Neurologic Manifestations
Signs and Symptoms
Heparin
Calcium heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action