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Cardiovascular Health Improvement Project (CHIP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02306200
Recruitment Status : Recruiting
First Posted : December 3, 2014
Last Update Posted : March 19, 2020
Sponsor:
Information provided by (Responsible Party):
Cristen Willer, PhD, University of Michigan

Brief 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.

Condition or disease
Aortic Aneurysm Aortic Dissection Aortic Stenosis Bicuspid Aortic Valve (BAV) Aortic Valve Disease

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 9999 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 40 Years
Official Title: Cardiovascular Health Improvement Project
Study Start Date : August 2013
Estimated Primary Completion Date : August 2053
Estimated Study Completion Date : August 2054


Group/Cohort
Aortic Disease
Patients with a diagnosis of any form of Aortic Disease
Controls
Patients without a diagnosis of Aortic Disease



Primary Outcome Measures :
  1. 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


Biospecimen Retention:   Samples With DNA
Blood, Tissue


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Outpatient clinic
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02306200


Contacts
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Contact: Tori Melendez, MSW 7342324779 torimel@med.umich.edu

Locations
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United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Tori Melendez, MSW    734-232-4779    torimel@med.umich.edu   
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Cristen Willer, PhD University of Michigan
Additional Information:

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Responsible Party: Cristen Willer, PhD, Assistant Professor of Internal Medicine, Assistant Professor of Human Genetics, University of Michigan
ClinicalTrials.gov Identifier: NCT02306200    
Other Study ID Numbers: HUM00052866
First Posted: December 3, 2014    Key Record Dates
Last Update Posted: March 19, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Cristen Willer, PhD, University of Michigan:
Aorta
Aortic Disease
Abdominal Aortic Aneurysm (AAA)
Thoracic Aortic Aneurysm (TAA)
Bicuspid Aortic Valve (BAV)
Aortic Dissection
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Valve Stenosis
Aneurysm, Dissecting
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Heart Valve Diseases
Heart Diseases
Ventricular Outflow Obstruction