- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00380185
Understanding the Genetic Basis of Atherosclerosis and Peripheral Arterial Disease (GenePAD)
The Genetic Determinants of Peripheral Arterial Disease
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Plaque build-up caused by atherosclerosis increases the risk of blood clots, heart attack, and stroke. Blockages of plaque can occur in different areas of the body. PAD, a circulatory disorder in which blockages occur in the peripheral arteries, is one manifestation of atherosclerosis. Individuals with PAD experience reduced blood flow to the legs, which may cause leg pain while walking. Coronary artery disease (CAD), in which plaque builds up in arteries leading to the heart, is another atherosclerosis-related condition. Individuals with PAD and CAD have similar atherosclerosis risk factors, but it remains unknown why some individuals develop one disease and not the other. Genetic differences may influence where atherosclerosis develops. The goal of the study is to identify genetic variations that may cause inherited differences in plaque distribution.
This study will enroll individuals with PAD who have been referred by their doctor for a coronary angiogram to confirm the presence of CAD. A control group composed of individuals who do not have PAD, but have similar risk factors for atherosclerosis, will also be enrolled. All participants will attend one study visit. They will undergo a coronary angiogram, a procedure in which a special dye is inserted intravenously into an artery of the heart. X-rays will be taken to document how blood flows through the artery. Questionnaires assessing quality of life, exercise habits, tobacco exposure, and family medical history will be completed. Participants will also undergo blood pressure measurements and blood collection for genetic analysis. Yearly follow-up phone calls will occur for 5 years to document any hospitalizations.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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California
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Stanford, California, Forente stater, 94305
- Stanford University
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New York
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New York, New York, Forente stater, 10029
- Mt. Sinai Medical Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Hemodynamically significant PAD, as documented by an ankle-brachial index less than 0.9; control group participants will not have PAD
- Received a referral for an elective coronary angiogram
- Suspected CAD
Exclusion Criteria:
- History of radiation treatment
- History of organ transplant
- History of viral diseases (i.e. HIV, hepatitis)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
---|
1
Subjects with no hemodynamically significant disease (NHSD) of the coronary or peripheral arteries
|
2
Subjects with coronary artery disease only
|
3
Subjects with both coronary artery disease and peripheral arterial disease
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Identifying genetic variations that may cause inherited differences in plaque distribution
Tidsramme: Measured at participants' study visit
|
Measured at participants' study visit
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: John P. Cooke, MD, PhD, Stanford University
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Flores AM, Schuler A, Eberhard AV, Olin JW, Cooke JP, Leeper NJ, Shah NH, Ross EG. Unsupervised Learning for Automated Detection of Coronary Artery Disease Subgroups. J Am Heart Assoc. 2021 Dec 7;10(23):e021976. doi: 10.1161/JAHA.121.021976. Epub 2021 Nov 30.
- Sadrzadeh Rafie AH, Stefanick ML, Sims ST, Phan T, Higgins M, Gabriel A, Assimes T, Narasimhan B, Nead KT, Myers J, Olin J, Cooke JP. Sex differences in the prevalence of peripheral artery disease in patients undergoing coronary catheterization. Vasc Med. 2010 Dec;15(6):443-50. doi: 10.1177/1358863X10388345.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1361
- R01HL075774 (U.S. NIH-stipend/kontrakt)
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