- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01742455
Assessment of Natural Bypasses in the Lower Limb
Quantitative Assessment of the Peripheral Artery Collateral Circulation in Patients With and Without Coronary Artery Disease (Pilot Study)
Study Overview
Status
Detailed Description
Background: Peripheral artery disease (PAD) of the lower extremities is due to arterial obstruction leading to reduced arterial flow during exercise and/or at rest. The disease is present in approximately 4 percent of persons >40 years of age, but in 15-20 percent of those >65 years. Claudication is the major symptom and can improve with pharmacotherapy or exercise rehabilitation. In patients with disabling claudication that persist despite exercise and pharmacotherapy or with critical limb ischemia (i.e. ischemic rest pain; ulcers or gangrene at risk of major amputation), revascularization therapies are indicated. However, in about 1/4 of these patients endovascular or surgical therapy fails or is not applicable, making alternative approaches necessary.1 Thus, promotion of angiogenesis, a process triggered by ischemia with sprouting of capillaries insufficient to provide adequate blood supply to jeopardized tissues, and arteriogenesis, which refers to positive remodeling of preformed collateral arterioles, i.e. collateral growth should be applied in these patients.2, 3 Despite the fact that numerous studies during the last decade pursued the important therapeutic strategy of improving collateral function in patients with PAD, there is currently no method available to quantify collateral arterial function of the lower limb and, thus, to determine therapeutic effects. Clinical studies investigating new therapeutic strategies for the promotion of peripheral collateral growth by application of growth factors and/or exercise rehabilitation have used imprecise and inadequate assessment methods and therefore determined only "weak" endpoints. In contrast to the coronary circulation, there is currently no gold standard available to document successful promotion of collateral growth in patients suffering from PAD.
Aim: The purpose of this study in patients undergoing elective coronary angiography with or without chronic stable coronary artery disease is to evaluate a new invasive method to quantify arterial collateral flow in the lower extremity.
Main hypothesis: Quantitative assessment of peripheral arterial collaterals by pressure-derived collateral flow index (CFIp) in the lower extremities is safe and feasible.
Methodology: Prospective exploratory trial. Primary study endpoint: Pressure-derived collateral flow index (CFIp) of the superficial femoral artery.
Potential significance: The results of this study will demonstrate that the concept of collateral flow index - which has been proven by our group in the coronary circulation - is a safe and feasible method for the quantitative assessment of peripheral limb collateral function. The results of this study may serve as preliminary data for larger clinical trials investigating therapeutic promotion of collaterals in patients with PAD and provide a reliable study endpoint.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Berne, Switzerland, 3010
- University Hospital Inselspital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age > 18 years
- Stable angina pectoris, electively referred for coronary angiography
- Written informed consent to participate in the study
Exclusion Criteria:
- Rest pain, ulceration or gangrene due to PAD (Rutherford 4-6)
- Significant stenoses (>50%) or occlusion of superficial femoral or profunda femoral artery
- Aortoiliac occlusion or significant stenoses (>50%)
- Aneurysm of abdominal aorta or iliac arteries
- Acute coronary syndrome
- Congestive heart failure NYHA III-IV
- Severe pulmonary arterial hypertension
- Severe hepatic or renal failure (creatinine clearance < 15ml/min)
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Pressure-derived collateral flow index (CFIp) of the superficial femoral artery
Time Frame: Baseline
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Baseline
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Collaborators and Investigators
Investigators
- Study Chair: Christian Seiler, MD, Prof., University Hospital Inselspital, Berne
- Principal Investigator: Tobias Traupe, MD, University Hospital Inselspital, Berne
Publications and helpful links
General Publications
- Traupe T, Gloekler S, de Marchi SF, Werner GS, Seiler C. Assessment of the human coronary collateral circulation. Circulation. 2010 Sep 21;122(12):1210-20. doi: 10.1161/CIRCULATIONAHA.109.930651. No abstract available.
- Seiler C. Collateral Circulation of the Heart. 1st ed. London: Springer-Verlag; 2009.
- Kalka C, Baumgartner I. Gene and stem cell therapy in peripheral arterial occlusive disease. Vasc Med. 2008;13(2):157-72. doi: 10.1177/1358863x08088616.
- De Vivo S, Palmer-Kazen U, Kalin B, Wahlberg E. Risk factors for poor collateral development in claudication. Vasc Endovascular Surg. 2005 Nov-Dec;39(6):519-24. doi: 10.1177/153857440503900609.
- van Royen N, Schirmer SH, Atasever B, Behrens CY, Ubbink D, Buschmann EE, Voskuil M, Bot P, Hoefer I, Schlingemann RO, Biemond BJ, Tijssen JG, Bode C, Schaper W, Oskam J, Legemate DA, Piek JJ, Buschmann I. START Trial: a pilot study on STimulation of ARTeriogenesis using subcutaneous application of granulocyte-macrophage colony-stimulating factor as a new treatment for peripheral vascular disease. Circulation. 2005 Aug 16;112(7):1040-6. doi: 10.1161/CIRCULATIONAHA.104.529552. Epub 2005 Aug 8.
- Traupe T, Ortmann J, Stoller M, Baumgartner I, de Marchi SF, Seiler C. Direct quantitative assessment of the peripheral artery collateral circulation in patients undergoing angiography. Circulation. 2013 Aug 13;128(7):737-44. doi: 10.1161/CIRCULATIONAHA.112.000516. Epub 2013 Jul 1.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 256/09 (Other Grant/Funding Number: ISF256/09)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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