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Enrolling by invitation NCT06976502

Health eHeart BioBank

Observational Heart Diseases Cardiac Diseases Vascular Diseases Cardiovascular Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Blood Draw, Tissue Collection, DNA Collection, Medical Chart Review.
Who it may be relevant to
Registry conditions: Heart Diseases, Cardiac Diseases, Vascular Diseases, Cardiovascular Diseases. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

The purpose of the Health eHeart BioBank is to collect and store specimen (e.g. blood, DNA, tissue) for future studies at the University of California, San Francisco (UCSF) that will help determine changes and identify molecular and genetic markers in the human body that might help increase our knowledge of heart disease and guide development of new diagnostic tools and treatments that may help rapidly detect heart disease and prevent and/or treat heart disease.

Interventions

  • Procedure Blood Draw
    Participants will be asked to contribute approximately 36 mL of blood using standard procedures and obtained at the time of a clinically ordered routine blood draw or a study ordered blood draw. Participants may be asked to contribute additional blood samples over the course of their participation in the study.
  • Procedure Tissue Collection
    If the participant is undergoing a clinically ordered procedure (e.g. heart surgery/biopsy/transplant), then they will be asked to contribute tissue to the study before any tissue is collected during the procedure. Most samples collected by the HeH BioBank will be tissue that would be normally discarded after the procedure.
  • Procedure DNA Collection
    Participants will be asked to contribute their DNA for Whole Genome Sequencing (WGS) to help identify genetic markers of heart disease. DNA will be obtained at the time of the blood draw or obtained through DNA collection kits administered to participants who are unable or unwilling to undergo a blood draw.
  • Other Medical Chart Review
    Demographic, clinical, and pathologic information will be extracted from the participant's medical record.

Primary outcome measures

  • Establish and Maintain a Centralized Biorepository [Time frame: Up to 10 years]

Eligibility criteria

Inclusion criteria

  • Age ≥ 18 years or older.

And at least one of the following:

  • Established patient seen at UCSF and/or is a current participant in a clinical study that utilizes the HeH BioBank for biospecimen collection.
  • Family member of a patient with cardiovascular disease.
  • Patient with no cardiovascular disease.

Exclusion criteria

  • Unwilling to consent to biospecimen collection through the HeH BioBank.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • University of California, San Francisco — San Francisco

Publications

  • Rahmutula D, Marcus GM, Wilson EE, Ding CH, Xiao Y, Paquet AC, Barbeau R, Barczak AJ, Erle DJ, Olgin JE. Molecular basis of selective atrial fibrosis due to overexpression of transforming growth factor-beta1. Cardiovasc Res. 2013 Sep 1;99(4):769-79. doi: 10.1093/cvr/cvt074. Epub 2013 Apr 23. PMID 23612580
  • Tseng ZH, Olgin JE, Vittinghoff E, Ursell PC, Kim AS, Sporer K, Yeh C, Colburn B, Clark NM, Khan R, Hart AP, Moffatt E. Prospective Countywide Surveillance and Autopsy Characterization of Sudden Cardiac Death: POST SCD Study. Circulation. 2018 Jun 19;137(25):2689-2700. doi: 10.1161/CIRCULATIONAHA.117.033427. PMID 29915095
  • Aouizerat BE, Vittinghoff E, Musone SL, Pawlikowska L, Kwok PY, Olgin JE, Tseng ZH. GWAS for discovery and replication of genetic loci associated with sudden cardiac arrest in patients with coronary artery disease. BMC Cardiovasc Disord. 2011 Jun 10;11:29. doi: 10.1186/1471-2261-11-29. PMID 21658281
  • Roberts JD, Hsu JC, Aouizerat BE, Pullinger CR, Malloy MJ, Kane JP, Olgin JE, Marcus GM. Impact of a 4q25 genetic variant in atrial flutter and on the risk of atrial fibrillation after cavotricuspid isthmus ablation. J Cardiovasc Electrophysiol. 2014 Mar;25(3):271-277. doi: 10.1111/jce.12317. Epub 2013 Dec 13. PMID 24237655
  • Roberts JD, Dewland TA, Glidden DV, Hoffmann TJ, Arking DE, Chen LY, Psaty BM, Olgin JE, Alonso A, Heckbert SR, Marcus GM. Impact of genetic variants on the upstream efficacy of renin-angiotensin system inhibitors for the prevention of atrial fibrillation. Am Heart J. 2016 May;175:9-17. doi: 10.1016/j.ahj.2016.02.002. Epub 2016 Feb 13. PMID 27179719
  • Roberts JD, Dewland TA, Longoria J, Fitzpatrick AL, Ziv E, Hu D, Lin J, Glidden DV, Psaty BM, Burchard EG, Blackburn EH, Olgin JE, Heckbert SR, Marcus GM. Telomere length and the risk of atrial fibrillation: insights into the role of biological versus chronological aging. Circ Arrhythm Electrophysiol. 2014 Dec;7(6):1026-32. doi: 10.1161/CIRCEP.114.001781. Epub 2014 Nov 8. PMID 25381796
  • Marcus GM, Smith LM, Glidden DV, Wilson E, McCabe JM, Whiteman D, Tseng ZH, Badhwar N, Lee BK, Lee RJ, Scheinman MM, Olgin JE. Markers of inflammation before and after curative ablation of atrial flutter. Heart Rhythm. 2008 Feb;5(2):215-21. doi: 10.1016/j.hrthm.2007.10.007. Epub 2007 Oct 7. PMID 18242542
  • Roberts JD, Longoria J, Poon A, Gollob MH, Dewland TA, Kwok PY, Olgin JE, Deo RC, Marcus GM. Targeted deep sequencing reveals no definitive evidence for somatic mosaicism in atrial fibrillation. Circ Cardiovasc Genet. 2015 Feb;8(1):50-7. doi: 10.1161/CIRCGENETICS.114.000650. Epub 2014 Nov 18. PMID 25406240

Identifiers

NCT: NCT06976502 · 24-40979

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗