Trial Outcomes & Findings for Characterization of Brachial Arterial t-PA Release, Endothelial Function, Obesity and Inflammation (NCT NCT00780481)

NCT ID: NCT00780481

Last Updated: 2017-07-14

Results Overview

tPA Release

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

13 participants

Primary outcome timeframe

Single Study day

Results posted on

2017-07-14

Participant Flow

The data for this study was lost. The total number of participants enrolled/completed was pulled from IRB records. Participant age was between 18-65 per protocol. All participants were enrolled in the United States. No other data is available

Participant milestones

Participant milestones
Measure
Bradykinin
Patients will have flow mediated vasodilation and radial artery tonometry performed. They will then receive 0, 10, 20, 40 ng/100cc/min of intrabrachial bradykinin. Strain gauge plethysmography and blood sampling at each dose will be done to evaluate t-PA release. Blood will also be drawn for other biomarkers. Bradykinin: Intrabrachial - 0, 10, 20, 40 ng/100cc/min over 5 minutes at each dose.
Overall Study
STARTED
13
Overall Study
COMPLETED
13
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Characterization of Brachial Arterial t-PA Release, Endothelial Function, Obesity and Inflammation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Bradykinin
n=13 Participants
Patients will have flow mediated vasodilation and radial artery tonometry performed. They will then receive 0, 10, 20, 40 ng/100cc/min of intrabrachial bradykinin. Strain gauge plethysmography and blood sampling at each dose will be done to evaluate t-PA release. Blood will also be drawn for other biomarkers. Bradykinin: Intrabrachial - 0, 10, 20, 40 ng/100cc/min over 5 minutes at each dose.
Age, Categorical
<=18 years
0 Participants
n=13 Participants
Age, Categorical
Between 18 and 65 years
13 Participants
n=13 Participants
Age, Categorical
>=65 years
0 Participants
n=13 Participants
Region of Enrollment
United States
13 participants
n=13 Participants

PRIMARY outcome

Timeframe: Single Study day

Population: Data was lost

tPA Release

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Single Study Day

Population: Data Lost

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Single Study Visit

Population: Data was lost

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Single Study Day

Population: Data was lost

Outcome measures

Outcome data not reported

Adverse Events

Bradykinin

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

James Muldowney

Vanderbilt University Medical Center

Phone: 615-936-1720

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place