Aortic AneurysmCHIPNCT02306200
Cardiovascular Health Improvement Project
An observational study of Aortic Aneurysm and Aortic Dissection, run by University of Michigan at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Aortic Aneurysm, Aortic Dissection, Bicuspid Aortic Valve (BAV)
- How many people
- 15,000 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Aug 2053
- How long will I take part?
- 40 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Outpatient clinic
Who may be able to join
- 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
Show all 9Show fewer
- Family history of aortic or vascular disease
- Other cardiovascular disease
- Healthy controls with no apparent cardiovascular disease
Who cannot join
- Not willing or able to sign the consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Lauren Humphrey-Stark, BS, 734-232-4779, ljeany@med.umich.edu
Jen McNamara, MS, 734-232-6180, jlmcnama@med.umich.edu
About this study
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.
Read the 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.
- Conditions
- Aortic Aneurysm, Aortic Dissection, Bicuspid Aortic Valve (BAV), Heart Failure, Cardiovascular Diseases
- Keywords
- Aorta, Abdominal Aortic Aneurysm (AAA), Thoracic Aortic Aneurysm (TAA), Bicuspid Aortic Valve (BAV), Aortic Dissection
- Medical subject headings
- Aortic Aneurysm, Aortic Dissection, Bicuspid Aortic Valve Disease, Heart Failure, Cardiovascular Diseases, Aortic Aneurysm, Abdominal, Aortic Aneurysm, Thoracic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Aortic Disease | Patients with a diagnosis of any form of Aortic Disease | |
| Controls | Patients without a diagnosis of Aortic Disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establishing a biobank of patients with Aortic Disease
Establish a biobank of blood, serum, plasma, tissue, and clinical data of patients with any form of aortic disease
Measured: 40 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2014 (estimated)
- Study startAug 2013
- Primary completionAug 2053 (estimated)
- Study completionAug 2053 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 15,000 participants (estimated)
- Target duration
- 40 Years
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marion Hofmann Bowman, University of Michigan
- Investigators
- Marion A Hofmann Bowman, PhD, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02306200
- Sponsor's protocol ID
- HUM00052866
- Acronym
- CHIP
- Status last verified
- Apr 2026
- First submitted
- 1 Dec 2014
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 33319384
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Health Improvement Project
- ClinicalTrials.gov ID
- NCT02306200
- Acronym / sponsor ID
- CHIP / HUM00052866
- Conditions
- Aortic Aneurysm, Aortic Dissection, Bicuspid Aortic Valve (BAV), Heart Failure, Cardiovascular Diseases
- Keywords
- Aorta, Abdominal Aortic Aneurysm (AAA), Thoracic Aortic Aneurysm (TAA), Bicuspid Aortic Valve (BAV), Aortic Dissection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Aug 2053 (estimated)
- Study completion
- Aug 2053 (estimated)
- First posted
- 3 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 40 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aortic Disease | – | –Patients with a diagnosis of any form of Aortic Disease |
| Controls | – | –Patients without a diagnosis of Aortic Disease |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Outpatient clinic
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (1 listed)
- Not willing or able to sign the consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Establishing a biobank of patients with Aortic Disease
Time frame: 40 years
Establish a biobank of blood, serum, plasma, tissue, and clinical data of patients with any form of aortic disease
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Derived from this study: PubMed 33319384Love-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marion A Hofmann Bowman, PhD, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Aneurysm and Aortic Dissection, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lauren Humphrey-Stark, BS (7342324779, ljeany@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establishing a biobank of patients with Aortic Disease (time frame: 40 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02306200, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026; AzTrials last refreshed its copy on 30 Oct 2026.