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NCT01848301 · ClinicalTrials.gov registry record · Phase 1
Endothelial Injury and Development of Coronary Intimal Thickening After Heart Transplantation
A Phase 1 study, sponsored by Gladwin, Mark, MD.
- Terminated
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT01848301 is a Phase 1 study that was terminated before completion, run by Gladwin, Mark, MD. The registered enrollment target is 12 participants.
The verdict
NCT01848301, a Phase 1 study, was terminated before completion, sponsored by Gladwin, Mark, MD.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
Coronary allograft vasculopathy (CAV) is the leading cause of late graft failure and second leading cause of late mortality after heart transplantation. CAV has been associated with a variety of traditional risk factors for atherosclerosis; however, immune mediated injury from development of de-novo donor-specific antibodies after transplantation also likely plays an important role. Similar to the progression of traditional atherosclerosis, it is likely that endothelial dysfunction is the precursor to the development of intimal thickening and CAV. The investigators hypothesize that coronary allograft vasculopathy after heart transplantation as defined by progressive neointimal hyperplasia is preceded by endothelial dysfunction, which in turn is at least partly mediated by donor specific antibodies. The investigators are proposing a prospective study in humans to test the above hypothesis and further mechanistically understand how CAV progresses. In this study the investigators will test for coronary endothelial function by infusing acetylcholine into the coronary artery and measure intimal hyperplasia by optical coherence tomography (OCT) and compare findings in patients with and without donor specific antibodies.
Interventions
- DRUG Acetylcholine
- DEVICE Optical Coherence Tomography
- PROCEDURE Brachial Artery Flow Mediated Dilation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2012-09 |
| Est. Completion | 2017-05-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01848301
The ClinicalTrials.gov registry entry for NCT01848301 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gladwin, Mark, MD, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Acetylcholine is the first listed.
NCT01848301 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01848301 about?
NCT01848301 is a clinical study titled "Endothelial Injury and Development of Coronary Intimal Thickening After Heart Transplantation". Coronary allograft vasculopathy (CAV) is the leading cause of late graft failure and second leading cause of late mortality after heart transplantation. CAV has been associated with a variety of traditional risk factors for atherosclerosis; however, immune mediated injury from development of de-novo...
What is the current status of trial NCT01848301?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2012-09. Estimated completion is 2017-05-01.
What interventions are being tested in trial NCT01848301?
The interventions under investigation include: Acetylcholine (DRUG), Optical Coherence Tomography (DEVICE), Brachial Artery Flow Mediated Dilation (PROCEDURE).
Who is sponsoring clinical trial NCT01848301?
This trial is sponsored by Gladwin, Mark, MD, which has 11 total clinical trials registered on ClinicalTrials.gov.
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