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Tissue-Type Plasminogen Activator (t-PA) Release Predicts Major Adverse Cardiac Events (MACE) in Patients With Non-critical Coronary Artery Disease
Plain-language guide to NCT00868855: phase 1 interventional trial of Bradykinin, 16 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00868855
- Phase
- phase 1
- Status
- terminated early
- Start
- 2003-12
- Completion (planned or actual)
- 2010-12
- Participants
- 16 (actual)
- Design
- na, open label (everyone knows who gets what), diagnostic
- Conditions studied
- Coronary Artery Disease
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 1 trial, researchers set out to test Bradykinin.
It had 1 arm (groups): 1 (experimental).
Bradykinin.
The registry classes the interventions as drug.
More on the Plan
It is produced by the endothelial cell lining of the blood vessels.
Impaired t-PA release upon bradykinin stimulation may indicate endothelial dysfunction that leads to the development of acute coronary syndrome.
In this project, the researchers will determine whether impaired t-PA release can predict future occurrence of acute coronary syndrome.
The study will involve individuals getting routine left heart cardiac catheterizations (indication for cardiac catheterization is solely based on clinical indication).
Who Took Part
The registry lists 16 actual participants took part.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Age \>18 year old male and female patients. All patients are referred for elective cardiac catheterization based on clinical indication.
The full record lists 3 inclusion and 10 exclusion criteria; among the exclusions: severe stenosis requires intervention; acute mi or acute coronary syndrome with enzyme elevation or ischemic ekg changes; prior history of myocardial infarction.
How the Study Was Run
It was run as a single-group and open-label study.
Nothing was hidden in this open-label Bradykinin study: the participants and staff both knew the treatment.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2003-12 with completion listed for 2010-12.
It ran at 1 site in United States.
Its stated primary purpose is diagnostic.
What Was Measured
Primary outcome: Mortality (time frame: 5 years).
What This Means in Plain Language
Put simply, this is a phase 1 trial of Bradykinin in 16 people.
Its size is small, so on its own it can only give an early look.
It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Bradykinin compound page, all human trials.
Our Notes on the Compound
Bradykinin: A 9-amino-acid peptide that widens blood vessels and causes swelling; given in research studies of blood flow.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.