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Protocol Details

Natural History of Uncommon Dyslipidemias, Rare Lipid Disorders and Unusual Atherosclerotic Conditions

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

001933-H

Sponsoring Institute

National Heart, Lung and Blood Institute (NHLBI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 10 Years
Max Age: 90 Years

Referral Letter Required

No

Population Exclusion(s)

None

Keywords

Uncommon Dyslipidemias;
Rare Lipid Disorders;
Unusual Atherosclerotic Conditions;
Lipoproteins;
Atherosclerosis;
TRIGLYCERIDES

Recruitment Keyword(s)

None

Condition(s)

Dyslipidemia;
Atherosclerosis

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Heart, Lung, and Blood Institute

Background:

The right amount of fats in the blood (cholesterol and triglycerides) are a key part of a healthy organism. Too much or too little of these fats may manifest as diseases (dyslipidemia). There are many causes for these abnormalities, but some are genetically determined and we would like to better understand the progression of these conditions over time.

Objective:

This natural history study aims to learn more about dyslipidemias; how they change over time; and how they respond to therapy. We also want to develop new diagnosis methods for these conditions. With the knowledge we will acquire we hope to provide new insights, new approaches and improve the overall health of these patients.

Eligibility:

Individuals aged 10 years and older, residing both within and outside the United States, who have or are suspected of having a disorder that causes changes in the levels of fats in their blood (genetic dyslipidemias).

Design:

Participants residing within and outside the United States will be screened. Their medical records will be reviewed. They may talk to researchers about their medical history by phone, telehealth, or in person.

All study visits are optional. Participants may visit the NIH up to 15 times per year, if needed.

Each visit may include a physical exam and blood tests. Participants may also have an electrocardiogram (EKG). The EKG measures the electrical activity when the heart beats. Stickers attached to wires will be placed on participants legs, arms, and chest. They will lie still for about 5 minutes.

In some cases, participants may remain in the study for up to 20 years.

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Eligibility

INCLUSION CRITERIA:

Affected Participants

-Male and female participants age >= 10 years.

-Subjects with confirmed or suspected rare disorder that causes lipid/lipoprotein abnormalities (dyslipidemia) or abnormal documented or referred atherosclerosis patterns.

-Only affected individuals (not healthy volunteers and for self-referred subjects independent of lipid and lipoprotein marker values.); subjects with laboratory or clinical presentation that in the opinion of the Principal Investigator, would alter the determination of normal

parameters for assays and screening tools development.

-Ability of the subject or Legally Authorized Representative (LAR) to understand and willingness to sign a written informed consent document.

Healthy Volunteers

-Participants must be healthy, with no known history of lipid disorders or related medical conditions.

-Participants must not be pregnant.

EXCLUSION CRITERIA:

-Patients with disorders that cause common secondary/lipoprotein alterations.

-Patients with any other findings that, in the opinion of the Principal Investigator, would preclude them from participating in the study.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Marcelo J. Amar, M.D.
National Heart, Lung and Blood Institute (NHLBI)
NIHBC 10 - CLINICAL CENTER BG RM 5D03
10 CENTER DR
BETHESDA MD 20892
(301) 402-0521
mamar@mail.nih.gov

Joy Lynne V. Freeman
National Heart, Lung and Blood Institute (NHLBI)
National Institutes of Health
Building 10
Room 5-3140
10 Center Drive
Bethesda, Maryland 20892
(301) 480-7632
joylynne.freeman@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT06676046

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