Cardiovascular Health Improvement Project

NCT ID: NCT02306200

Last Updated: 2025-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

9999 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-08-31

Study Completion Date

2053-08-31

Brief Summary

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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

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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.

Conditions

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Aortic Aneurysm Aortic Dissection Bicuspid Aortic Valve (BAV) Heart Failure Cardiovascular Diseases

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Aortic Disease

Patients with a diagnosis of any form of Aortic Disease

No interventions assigned to this group

Controls

Patients without a diagnosis of Aortic Disease

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Marion Hofmann Bowman

Associate Professor of Internal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marion A Hofmann Bowman, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Lauren Humphrey-Stark, BS

Role: CONTACT

7342324779

Jen McNamara, MS

Role: CONTACT

734-232-6180

Facility Contacts

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Lauren Humphrey-Stark, BS

Role: primary

7342324779

Jen McNamara, MS

Role: backup

734-232-6180

References

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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.

Reference Type DERIVED
PMID: 33319384 (View on PubMed)

Other Identifiers

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HUM00052866

Identifier Type: -

Identifier Source: org_study_id

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