Identify Clinical Conditions That Increase Circulating DNA Levels (BARDA II)

University of Florida

Status: Completed

Conditions: Pulmonary Embolism; Autoimmune Disease; Myocardial Infarction; Pregnancy

Treatments: Other: One time blood draw to look at patient's DNA

Study type: Observational

Funder types: Other

Identifiers

NCT01815996

407-2012

IRB201702171 (Other Identifier)

Details and patient eligibility

About

The investigators are developing a test that is expected to measure the amount of radiation a patient has been exposed to after a nuclear bomb. The investigator will do this by measuring the DNA in the patients blood from cells killed by the radiation.

Many diseases and medical conditions can put DNA in the blood. The investigator needs to know how much DNA in order to better interpret our radiation detection test. Therefore, the investigator is collecting blood from several patients with different diseases or medical conditions and also healthy volunteers to measure their DNA content.

Patients that will be included in this study are pregnant women, patients who have suffered a pulmonary embolism within the past 48 hours, patients who have suffered from myocardial infarction in the past 48 hours, patients with autoimmune diseases and health patients.

Full description

The investigator will collect 8 mL (one and one half teaspoons) of blood one time only. The investigator may also collect the patient's past medical history, test results and disease treatment.

Enrollment: 130 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Patients must be adults in one of the following categories:

   • Pregnant
   • Suffered a pulmonary embolism within the past 48 hours
   • Myocardial infarction in the past 48 hours
   • Diagnosed with an autoimmune disease
   • Adults age 18-80
   • Self-declared healthy adults

2. Patients must be willing to undergo a blood draw

3. Patients must provide study-specific informed consent prior to study entry

Exclusion criteria

1. Patients not meeting the above inclusion criteria

Trial design

130 participants in 5 patient groups

Pregnant Women

Description:

Females between the age of 18-80 who are pregnant One time blood draw to look at patient's DNA

Treatment:

Other: One time blood draw to look at patient's DNA

Pulmonary Embolism Patients

Description:

Male and Female patients that have suffered a pulmonary embolism within the past 48 hours One time blood draw to look at patient's DNA

Treatment:

Other: One time blood draw to look at patient's DNA

Myocardial Patients

Description:

Male and Female patients who have myocardial infarction in the past 48 hours. One time blood draw to look at patient's DNA

Treatment:

Other: One time blood draw to look at patient's DNA

Autoimmune Patients

Description:

Male and Female patients that have been diagnosed with an Autoimmune disease One time blood draw to look at patient's DNA

Treatment:

Other: One time blood draw to look at patient's DNA

Healthy Controls

Description:

Self-declared healthy adults (men and women). One time blood draw to look at patient's DNA

Treatment:

Other: One time blood draw to look at patient's DNA