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Recruiting NCT02306200

Cardiovascular Health Improvement Project

Observational Aortic Aneurysm Aortic Dissection Bicuspid Aortic Valve (BAV) Heart Failure

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
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Aortic Aneurysm, Aortic Dissection, Bicuspid Aortic Valve (BAV), Heart Failure. Basic parameters: No limits · 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 goal of this project is to establish a biobank of clinical information, DNA, plasma, and aortic tissue samples from patients with cardiovascular disease as well as healthy controls.

Detailed description

The goal of this project is to establish a biobank of clinical information, DNA, plasma, and aortic tissue samples from patients with cardiovascular disease as well as healthy controls. The aims of the study are to collect biological specimens (blood, plasma, serum, aortic tissue) and family history; establish a biobank, establish a comprehensive database with information from consented patients, and provide researchers with high quality well annotated DNA samples with demographic and clinical information.

Primary outcome measures

  • Establishing a biobank of patients with Aortic Disease [Time frame: 40 years]

Eligibility criteria

Inclusion criteria

  • Any patient over the age of 18 who is able/willing to give informed consent
  • Patients <18 years of age with parental consent and assent (if assent is applicable for their age)
  • Diagnosis of:
  • aortic pathology potentially due to a known or suspected inherited condition
  • Idiopathic aortic aneurysm
  • Interesting of novel vascular pathology in the aorta or main branches
  • Family history of aortic or vascular disease
  • Other cardiovascular disease
  • Healthy controls with no apparent cardiovascular disease

Exclusion criteria

\- Not willing or able to sign the consent

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
Case-control

Study locations

United States · 1 center
  • University of Michigan — Ann Arbor

Publications

  • Love-Nichols J, Uhlmann WR, Arscott P, Willer C, Hornsby W, Roberts JS. A survey of aortic disease biorepository participants' preferences for return of research genetic results. J Genet Couns. 2021 Jun;30(3):645-655. doi: 10.1002/jgc4.1341. Epub 2020 Dec 14. PMID 33319384

Identifiers

NCT: NCT02306200 · HUM00052866

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗