Peripheral CollateralsNCT01742455
Assessment of Natural Bypasses in the Lower Limb
An observational study of Peripheral Collaterals and Arteriogenesis, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Concerning the promotion of peripheral collateral growth, clinical studies investigating new therapeutic strategies have used imprecise assessment methods and therefore determined only "weak" endpoints. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Collaterals, Arteriogenesis, Coronary Artery Disease
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2010to Jan 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Thirty patients with stable angina pectoris electively referred for coronary angiography to our department who give written informed consent.
Who may be able to join
- Age > 18 years
- Stable angina pectoris, electively referred for coronary angiography
- Written informed consent to participate in the study
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quantitative Assessment of the Peripheral Artery Collateral Circulation in Patients With and Without Coronary Artery Disease (Pilot Study)
Concerning the promotion of peripheral collateral growth, clinical studies investigating new therapeutic strategies have used imprecise 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 peripheral artery disease. Therefore, the purpose of this study is to evaluate a new invasive method to quantify arterial collateral flow in the lower extremity in patients undergoing elective coronary angiography.
Read the 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.
- Keywords
- Peripheral artery disease, Arterial Occlusive Diseases, Vascular Diseases, Cardiovascular Diseases, Coronary Artery Disease, Myocardial Ischemia, Arteriosclerosis, Pathologic Processes
- Medical subject headings
- Coronary Artery Disease, Peripheral Arterial Disease, Arterial Occlusive Diseases, Vascular Diseases, Cardiovascular Diseases, Myocardial Ischemia, Arteriosclerosis, Pathologic Processes
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure-derived collateral flow index (CFIp) of the superficial femoral artery
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2012 (estimated)
- Study startFeb 2010
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Peripheral CollateralsStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Heart Foundation, Swiss National Science Foundation
- Responsible party
- Principal investigator, Christian Seiler, Insel Gruppe AG, University Hospital Bern
- Investigators
- Christian Seiler, MD, Prof., Study chair, Insel Gruppe AG, University Hospital BernTobias Traupe, MD, Principal investigator, Insel Gruppe AG, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01742455
- Sponsor's protocol ID
- 256/09
- Status last verified
- Jun 2013
- First submitted
- 27 Nov 2012
- Last updated
- 18 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18593804De 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.
PubMed 16382273van 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.
PubMed 16087795Traupe 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.
PubMed 20855668Traupe 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.
PubMed 23817577
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Assessment of the Peripheral Artery Collateral Circulation in Patients With and Without Coronary Artery Disease (Pilot Study)
- ClinicalTrials.gov ID
- NCT01742455
- Acronym / sponsor ID
- 256/09
- Keywords
- Peripheral artery disease, Arterial Occlusive Diseases, Vascular Diseases, Cardiovascular Diseases, Coronary Artery Disease, Myocardial Ischemia, Arteriosclerosis, Pathologic Processes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Swiss Heart Foundation, Swiss National Science Foundation
- Study start
- Feb 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 5 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Concerning the promotion of peripheral collateral growth, clinical studies investigating new therapeutic strategies have used imprecise 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 peripheral artery disease. Therefore, the purpose of this study is to evaluate a new invasive method to quantify arterial collateral flow in the lower extremity in patients undergoing elective coronary angiography.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Thirty patients with stable angina pectoris electively referred for coronary angiography to our department who give written informed consent.
Key inclusion criteria (3 listed)
- Age > 18 years
- Stable angina pectoris, electively referred for coronary angiography
- Written informed consent to participate in the study
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pressure-derived collateral flow index (CFIp) of the superficial femoral artery
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2013.
- BackgroundSeiler C. Collateral Circulation of the Heart. 1st ed. London: Springer-Verlag; 2009.
- Background: PubMed 18593804Kalka C, Baumgartner I. Gene and stem cell therapy in peripheral arterial occlusive disease. Vasc Med. 2008;13(2):157-72. doi: 10.1177/1358863x08088616.
- Background: PubMed 16382273De 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.
- Background: PubMed 16087795van 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.
- Background: PubMed 20855668Traupe 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.
- Derived from this study: PubMed 23817577Traupe 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.
- Investigators' websiteLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Seiler, MD, Prof. study chair
Insel Gruppe AG, University Hospital Bern
Tobias Traupe, MD principal investigator
Insel Gruppe AG, University Hospital Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Collaterals and Arteriogenesis, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure-derived collateral flow index (CFIp) of the superficial femoral artery (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01742455, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2013.