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Status:

COMPLETED

The Role of Nitrite in Preconditioning Mediated Tolerance to Ischemic Stress

Lead Sponsor:

National Heart, Lung, and Blood Institute (NHLBI)

Conditions:

Ischemic Stress

Transient Non-Lethal Ischemia

Eligibility:

All Genders

18-45 years

Phase:

PHASE1

Brief Summary

Many studies have shown that if the human body is stressed by a lack of blood flow for a short period of time, the body develops defenses to make the body more resistant to a future stress from lack o...

Detailed Description

Many studies have shown that if the human body is stressed by a lack of blood flow for a short period of time, the body develops defenses to make the body more resistant to a future stress from lack o...

Eligibility Criteria

Inclusion

  • INCLUSION CRITERIA:
  • Subjects must be 18-45 years of age.
  • Subject must be in good health.
  • Subjects must provide informed, written consent for participation in this study.
  • Female subjects of childbearing age must have a negative pregnancy test.
  • EXCLUSION CRITERIA:
  • Subjects with a history of cardiac, pulmonary, peripheral vascular, or mitochondrial disease or diabetes mellitus.
  • Subjects with a history or evidence of present or past hypertension (blood pressure greater than 140/90 mmHg), hypercholesterolemia (LDL cholesterol greater than 160 mg/dL).
  • Subjects with abnormal EKG other than sinus bradycardia.
  • Subjects who have a history of smoking within three months.
  • Subjects with anemia (defined as hemoglobin less than 9 g/dL).
  • BMI greater than 30.
  • Subjects with a history of reaction to a medication or other substance characterized by dyspnea and cyanosis will not participate in this study.
  • Subjects with G6PD deficiency.
  • Subjects with a baseline methemoglobin level greater than 1.5%.
  • Lactating females who are breastfeeding, will not participate since nitrite crosses into breast milk and could cause methemoglobinemia in the infant.
  • No volunteer subject will be allowed to take any prescription medication (oral contraceptive agents are allowed). Vitamin supplements, herbal preparations, nutriceuticals or other 'alternative therapies' must be stopped for two weeks prior to study and aspirin, tylenol and NSAIDs must also be discontinued two weeks prior to study.
  • Subjects with a blood pressure of less than 90/60 mmHg or mean arterial pressure (MAP) less than 70 mmHg on the study day will be excluded from the protocol.
  • Positive for HIV or hepatitis A or B or positive for syphilis.
  • Subjects with a history of placement or insertion of any metal devices including pacemakers, cardiac defibrillators, cochlear implants, aneurysm clips, neural stimulators, insulin pumps or foreign bodies, such as, metal shavings will be excluded from participation in the MRS.
  • Subjects with a history of claustrophobia or an inability to lie on their backs will be excluded from the MRS sub-study.

Exclusion

    Key Trial Info

    Start Date :

    November 1 2005

    Trial Type :

    INTERVENTIONAL

    End Date :

    June 9 2007

    Estimated Enrollment :

    135 Patients enrolled

    Trial Details

    Trial ID

    NCT00250185

    Start Date

    November 1 2005

    End Date

    June 9 2007

    Last Update

    July 2 2017

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, United States, 20892