Transplant Coronary Artery DiseaseCAS-POHTNCT01546870
Coronary Artery Study in Pediatric Heart Transplantation
An observational study of Transplant Coronary Artery Disease, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
Trial summary
Transplant coronary artery disease (TCAD) is a significant cause of morbidity and mortality in pediatric heart transplantation (PHT). Understanding the pathophysiology and early detection along with attempted medical management are crucial in preventing advancement of the disease and retransplantation or mortality. Read more about this study
- Who is it for?
- Ages 7 to 21 years
- Conditions the study is for
- Transplant Coronary Artery Disease
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Apr 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric heart transplant recipients
Who may be able to join
- less than 21 years and above 7 years of age
Who cannot join
- clinically significant coronary artery disease on angiography and inability to undergo IVUS
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Children's hospital
Little Rock, Arkansas, 72223
About this study
Transplant coronary artery disease (TCAD) is a significant cause of morbidity and mortality in pediatric heart transplantation (PHT). Understanding the pathophysiology and early detection along with attempted medical management are crucial in preventing advancement of the disease and retransplantation or mortality. Coronary angiogram, although routinely used is insensitive to detect early TCAD. Measurement of fractional flow reserve (FFR), coronary flow reserve (CFR) and index of microvascular resistance (IMR) using a doppler pressure and flow intracoronary wire may be more sensitive in evaluating the integrity of coronary vasculature and thus detect pre clinical TCAD. To the best of the investigators knowledge, measurement of these parameters has not been previously reported in PHT.
- Conditions
- Transplant Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| pediatric heart transplant recipients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical coronary artery disease
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionApr 2012
- Study completionApr 2012
Why it stopped: never approved by IRB
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Transplant Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Arkansas
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01546870
- Sponsor's protocol ID
- ArkansasChRI
- Acronym
- CAS-POHT
- Status last verified
- Jun 2016
- First submitted
- 3 Mar 2012
- Last updated
- 20 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Fearon WF, Hirohata A, Nakamura M, Luikart H, Lee DP, Vagelos RH, Hunt SA, Valantine HA, Fitzgerald PJ, Yock PG, Yeung AC. Discordant changes in epicardial and microvascular coronary physiology after cardiac transplantation: Physiologic Investigation for Transplant Arteriopathy II (PITA II) study. J Heart Lung Transplant. 2006 Jul;25(7):765-71. doi: 10.1016/j.healun.2006.03.003. Epub 2006 May 24.
PubMed 16818118
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Artery Study in Pediatric Heart Transplantation
- ClinicalTrials.gov ID
- NCT01546870
- Acronym / sponsor ID
- CAS-POHT / ArkansasChRI
- Conditions
- Transplant Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: never approved by IRB
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Collaborators
- University of Arkansas
- Study start
- Apr 2012
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 7 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Transplant coronary artery disease (TCAD) is a significant cause of morbidity and mortality in pediatric heart transplantation (PHT). Understanding the pathophysiology and early detection along with attempted medical management are crucial in preventing advancement of the disease and retransplantation or mortality. Coronary angiogram, although routinely used is insensitive to detect early TCAD. Measurement of fractional flow reserve (FFR), coronary flow reserve (CFR) and index of microvascular resistance (IMR) using a doppler pressure and flow intracoronary wire may be more sensitive in evaluating the integrity of coronary vasculature and thus detect pre clinical TCAD. To the best of the investigators knowledge, measurement of these parameters has not been previously reported in PHT.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pediatric heart transplant recipients | – | – |
Who may qualify
- Ages
- 7 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric heart transplant recipients
Key inclusion criteria (1 listed)
- less than 21 years and above 7 years of age
Key exclusion criteria (1 listed)
- clinically significant coronary artery disease on angiography and inability to undergo IVUS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical coronary artery disease
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2016.
- Background: PubMed 16818118Fearon WF, Hirohata A, Nakamura M, Luikart H, Lee DP, Vagelos RH, Hunt SA, Valantine HA, Fitzgerald PJ, Yock PG, Yeung AC. Discordant changes in epicardial and microvascular coronary physiology after cardiac transplantation: Physiologic Investigation for Transplant Arteriopathy II (PITA II) study. J Heart Lung Transplant. 2006 Jul;25(7):765-71. doi: 10.1016/j.healun.2006.03.003. Epub 2006 May 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transplant Coronary Artery Disease, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical coronary artery disease (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01546870, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2016.