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Minority Health Genomics and Translational Research Bio-Repository Database (MH-GRID)-2.0

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ClinicalTrials.gov Identifier: NCT02290392
Recruitment Status : Completed
First Posted : November 14, 2014
Last Update Posted : August 12, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Human Genome Research Institute (NHGRI) )

Tracking Information
First Submitted Date November 11, 2014
First Posted Date November 14, 2014
Last Update Posted Date August 12, 2019
Study Start Date November 11, 2014
Actual Primary Completion Date July 16, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 1, 2018)
To complete the original MHGRID primary outcome analyses by defining the genetic, behavioral , and social-environmental determinants of severe hypertension and other cardiometabolic disorders in individuals of African ancestry. [ Time Frame: one time analysis ]
To complete the original MH-GRID primary outcome analyses by defining the genetic, behavioral , and social-environmental determinants of severe hypertension and other cardio- metabolic disorders in individuals of African ancestry.
Original Primary Outcome Measures
 (submitted: November 11, 2014)
The primary outcome variables include severe hypertension and hypertension induced kidney damage. [ Time Frame: On going ]
Change History Complete list of historical versions of study NCT02290392 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 1, 2018)
The secondary outcome variables include obesity, coronary heart disease and metabolic disease syndrome. Intervening variables include genetics, behavioral, ancestry, social, biological, and environmental. [ Time Frame: one time analysis ]
The secondary outcome variables include obesity, coronary heart disease and metabolic disease syndrome. Intervening variables includegenetics, behavioral, ancestry, social, biological, and environmental.
Original Secondary Outcome Measures
 (submitted: November 11, 2014)
The secondary outcome variables include obesity, coronary heart disease and metabolic disease syndrome. Intervening variables include genetics, behavioral, ancestry, social, biological, and environmental. [ Time Frame: On going ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Minority Health Genomics and Translational Research Bio-Repository Database (MH-GRID)-2.0
Official Title The Minority Health Genomics and Translational Research BIo-Repository Database (MH-GRID)-2.0
Brief Summary

Background:

- High blood pressure is a common problem. It can cause heart attacks, strokes, and kidney failure. It affects African Americans more than other racial groups. Data were collected from over a thousand African Americans across the country. The data were put into a database (MH-GRID). The data were about genes, diet, sleep, body mass index. They also cover stress and access to healthy foods and parks. Researchers at NIH will study these data in new ways. They want to learn more about the connection between African Americans and high blood pressure.

Objective:

- To study MH-GRID data to find the causes of severe high blood pressure and other cardio-metabolic problems in people of African ancestry.

Eligibility:

- African Americans age 30 55 with severe high blood pressure were used in the MH-GRID study. No new participants will be enrolled in this study.

Design:

- Researchers will examine data from the MH-GRID study.

Detailed Description

The etiology of racial/ethnic differences in health involves dynamic interactions between

genetic, behavioral and social-environmental determinants. Despite this, the field lacks robust

datasets that integrate these determinants with clinical assessments in minority patient cohorts. The Minority Health Genomics and Translational Research Bio-repository Database (MHGRID) Network infrastructure facilitated the collection of biospecimens and related multidimensional data elements within a consortium of minority-serving clinics. This initiative expands the diversity of ancestral groups in national genomic medicine datasets and promises to accelerate the translation of personalized medicine into minority communities. The MH-GRID project was initiated by Dr. Gibbons (founding PI) prior to becoming an NIH investigator. The MH-GRID project has completed its participant recruitment activities, closed out its NIH funding and now represents an existing dataset and biorepository that is being transferred to NHGRI for ongoing secondary analyses. A variety of investigations will be conducted on this existing dataset. The primary outcome variables include severe hypertension and hypertension induced kidney damage. Secondary outcome variables include obesity, coronary heart disease and metabolic disease syndrome. Intervening variables include genetics, behavioral (i.e. sleep quality, health literacy, smoking, diet, body mass index), ancestry, social (i.e. socioeconomic status, racial discrimination, stress, social depreivation), biological (i.e. insulin resistance, cholesterol, inflammatory markers), and environmental (i.e. neighborhood, access to healthy foods, parks).

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Not Provided
Condition Hypertension
Intervention Not Provided
Study Groups/Cohorts 1
African Americans age 30-55 years with severe controlled HTN or severe resistant HTN.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 11, 2014)
1692
Original Estimated Enrollment Same as current
Actual Study Completion Date July 16, 2019
Actual Primary Completion Date July 16, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria
  • INCLUSION CRITERIA:
  • The MH-GRID Project s inclusion criteria included AA age 30-55 years
  • Severe controlled HTN or severe resistant HTN.

EXCLUSION CRITERIA:

  • Exclusion criteria involved patients with secondary forms of HTN, primary forms of kidney disease or major co-morbidities (e.g. diabetes, heart failure, end-stage renal failure, HIV, and liver disease).
  • Children <18 were not enrolled in the protocol.
Sex/Gender
Sexes Eligible for Study: All
Ages 30 Years to 55 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02290392
Other Study ID Numbers 999915011
15-HG-N011
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Human Genome Research Institute (NHGRI) )
Study Sponsor National Human Genome Research Institute (NHGRI)
Collaborators National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Gary H Gibbons, M.D. National Heart, Lung, and Blood Institute (NHLBI)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date August 7, 2019