CHIP: Cardiovascular Health Improvement Project

Sponsor

University of Michigan (Other)

Overall Status

Recruiting

CT.gov ID

NCT02306200

Collaborator

(none)

9,999

Enrollment

Location

444

Duration (Months)

22.5

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
Aortic Aneurysm Aortic Dissection Bicuspid Aortic Valve (BAV) Heart Failure Cardiovascular Diseases

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

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

9999 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Cardiovascular Health Improvement Project

Study Start Date :

Aug 1, 2013

Anticipated Primary Completion Date :

Aug 1, 2050

Anticipated Study Completion Date :

Aug 1, 2050

Arms and Interventions

Arm	Intervention/Treatment
Aortic Disease Patients with a diagnosis of any form of Aortic Disease
Controls Patients without a diagnosis of Aortic Disease

Outcome Measures

Primary Outcome Measures

Establishing a biobank of patients with Aortic Disease [40 years]
Establish a biobank of blood, serum, plasma, tissue, and clinical data of patients with any form of aortic disease

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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