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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04253769
Other study ID # 999920040
Secondary ID 20-H-N040
Status Not yet recruiting
Phase
First received
Last updated
Start date February 14, 2020
Est. completion date December 31, 2030

Study information

Verified date January 31, 2020
Source National Institutes of Health Clinical Center (CC)
Contact Sara E Hauffe
Phone (301) 385-2828
Email sara.hauffe@nih.gov
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Background:

The National Heart, Lung, and Blood Institute (NHLBI) conducts clinical trials that look at new ways to prevent, detect, or treat disease. It wants to create an NHLBI Recruitment Registry that lets people sign up to be contacted for NHLBI studies. It also wants to make sure that the data people share about themselves is safely stored. Researchers will be able to use this registry to prescreen people for clinical trials.

Objective:

To create and maintain an NHLBI research participant recruitment registry. This is an observational registry for collecting, storing, and providing access to data on people with a disease or condition of interest, or as a healthy volunteer to the NHLBI.

Eligibility:

People who contact the NIH to participate in an NHLBI IRB-approved study

Design:

Researchers will contact participants by telephone to obtain informed consent verbally.

Participants will give the following data:

- name

- date of birth

- phone number

- address

- email address

- diagnosis (if applicable)

- referring provider.

Participants will share how they heard of the study. They may give their medical records. They may be asked if they were enrolled in an NHLBI study in the past.

Participants will be asked if they would like to be contacted for other current or future studies. If they say no, they will not be contacted. But their data will stay in the database. They can also withdraw from the registry. If they do, their reason will be recorded in the database.

The registry will be created and maintained by the Office of the Clinical Director at NHLBI.


Description:

The objectives of this protocol are to develop and maintain an NHLBI research participant recruitment registry. An NHLBI Recruitment Registry will allow research teams to prescreen, safely store Protected Identifiable Information (PII) and contact potential research participants for NHLBI IRB approved protocols.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 99999
Est. completion date December 31, 2030
Est. primary completion date December 31, 2030
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility - INCLUSION CRITERIA:

Any potential participant who contacts the NIH for study participation

EXCLUSION CRITERIA:

None

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States National Heart, Lung and Blood Institute (NHLBI) Bethesda Maryland

Sponsors (1)

Lead Sponsor Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The primary outcome is to develop and maintain an NHLBI research participant recruitment registry. Registry will allow research teams to prescreen, safely store Protected Identifiable Information (PII) and contact potential research participants for NHLBI IRB approved protocols. Ongoing
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT00001620 - Screening for Hematology Branch Protocols