NCT01742455

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

November 27, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 5, 2012

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

June 18, 2013

Status Verified

June 1, 2013

Enrollment Period

2.9 years

First QC Date

November 27, 2012

Last Update Submit

June 17, 2013

Conditions

Peripheral CollateralsArteriogenesisCoronary Artery Disease

Keywords

Peripheral artery diseaseArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesCoronary Artery DiseaseMyocardial IschemiaArteriosclerosisPathologic Processes

Outcome Measures

Primary Outcomes (1)

  • Pressure-derived collateral flow index (CFIp) of the superficial femoral artery

    Baseline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Thirty patients with stable angina pectoris electively referred for coronary angiography to our department who give written informed consent.

You may qualify if:

  • Age \> 18 years
  • Stable angina pectoris, electively referred for coronary angiography
  • Written informed consent to participate in the study

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Inselspital

Bern, 3010, Switzerland

Location

Related Publications (6)

  • Seiler C. Collateral Circulation of the Heart. 1st ed. London: Springer-Verlag; 2009.

    BACKGROUND

  • 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.

    PMID: 18593804BACKGROUND

  • 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.

    PMID: 16382273BACKGROUND

  • 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.

    PMID: 16087795BACKGROUND

  • 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.

    PMID: 20855668BACKGROUND

  • 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.

    PMID: 23817577DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples (routine)

MeSH Terms

Conditions

Coronary Artery DiseasePeripheral Arterial DiseaseArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesMyocardial IschemiaArteriosclerosisPathologic Processes

Condition Hierarchy (Ancestors)

Coronary DiseaseHeart DiseasesAtherosclerosisPeripheral Vascular DiseasesPathological Conditions, Signs and Symptoms

Study Officials

  • Christian Seiler, MD, Prof.

    Insel Gruppe AG, University Hospital Bern

    STUDY CHAIR

  • Tobias Traupe, MD

    Insel Gruppe AG, University Hospital Bern

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Co-Chairman of Cardiology

Study Record Dates

First Submitted

November 27, 2012

First Posted

December 5, 2012

Study Start

February 1, 2010

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

June 18, 2013

Record last verified: 2013-06

Locations

CH(1)