Complex Aortic SurgeryCARENCT01211548
Coronary CT Angiography in Aneurysms Repaired With Open or Endovascular Approach
An observational study of Complex Aortic Surgery, run by The Cleveland Clinic.
Trial summary
This proposal is for the pilot study that will inform the conduct of a larger prospective randomized controlled trial to guide perioperative work up and the cost/utility of CTCA (high definition CT coronary angiography.) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complex Aortic Surgery
- What is being tested?
- contrast CTA of the CAP
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Feb 2011to Jul 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients being considered for a complex aortic surgery and undergoing medically indicated contrast enhanced CT aortic angiography of the chest abdomen and pelvis will be includedRaw data from CT coronary angiography will be available from all patients.
Who may be able to join
- patients being considered for a complex aortic surgery and undergoing medically indicated contrast enhanced CT aortic angiography of the chest abdomen and pelvis
Who cannot join
- Patients with contraindications to undergoing CT coronary angiography
- coronary revascularization within the last six months
- renal dysfunction in whom the treating physician has decided a contrast enhanced CT scan is not warranted as part of the routine clinical work up
About this study
This proposal is for the pilot study that will inform the conduct of a larger prospective randomized controlled trial to guide perioperative work up and the cost/utility of CTCA (high definition CT coronary angiography.)
Read the detailed description
This proposal is for a pilot study that will inform the conduct of a prospective, blinded randomized controlled trial designed to determine the cost effectiveness of an algorithm for pre operative cardiac risk stratification that uses coronary CT angiography. In addition perioperative and long-term cardiac event rate will be recorded to determine if there is any difference in these rates between the 2 groups.
- Conditions
- Complex Aortic Surgery
- Being tested
- contrast CTA of the CAP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
contrast CTA of the CAPOther
CT coronary angiography results will be reported for all patients by adjudicators blinded to their inclusion in the study.
| Study group | Role | What they receive |
|---|---|---|
| contrast CTA of the CAP | All patients being considered for a complex aortic surgery and undergoing medically indicated contrast enhanced CT aortic angiography of the chest abdomen and pelvis will be includedRaw data from CT coronary angiography will be available from all patients. Receives: Other: contrast CTA of the CAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome for the pilot study will be to assess feasibility of processes as set out in the specific aims.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2010 (estimated)
- Study startFeb 2011
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Aortic SurgeryStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01211548
- Sponsor's protocol ID
- 10-573
- Other IDs
- PVSS1005TM
- Acronym
- CARE
- Status last verified
- Mar 2017
- First submitted
- 9 Sep 2010
- Last updated
- 7 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary CT Angiography in Aneurysms Repaired With Open or Endovascular Approach
- ClinicalTrials.gov ID
- NCT01211548
- Acronym / sponsor ID
- CARE / 10-573
- Conditions
- Complex Aortic Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 29 Sep 2010 (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.
This proposal is for the pilot study that will inform the conduct of a larger prospective randomized controlled trial to guide perioperative work up and the cost/utility of CTCA (high definition CT coronary angiography.)
Detailed description
This proposal is for a pilot study that will inform the conduct of a prospective, blinded randomized controlled trial designed to determine the cost effectiveness of an algorithm for pre operative cardiac risk stratification that uses coronary CT angiography. In addition perioperative and long-term cardiac event rate will be recorded to determine if there is any difference in these rates between the 2 groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| contrast CTA of the CAP | – | Other: contrast CTA of the CAPAll patients being considered for a complex aortic surgery and undergoing medically indicated contrast enhanced CT aortic angiography of the chest abdomen and pelvis will be includedRaw data from CT coronary angiography will be available from all patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients being considered for a complex aortic surgery and undergoing medically indicated contrast enhanced CT aortic angiography of the chest abdomen and pelvis will be includedRaw data from CT coronary angiography will be available from all patients.
Key inclusion criteria (1 listed)
- patients being considered for a complex aortic surgery and undergoing medically indicated contrast enhanced CT aortic angiography of the chest abdomen and pelvis
Key exclusion criteria (3 listed)
- Patients with contraindications to undergoing CT coronary angiography
- coronary revascularization within the last six months
- renal dysfunction in whom the treating physician has decided a contrast enhanced CT scan is not warranted as part of the routine clinical work up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| contrast CTA of the CAPCT coronary angiography results will be reported for all patients by adjudicators blinded to their inclusion in the study. | Other | contrast CTA of the CAP |
Primary outcome
The primary outcome for the pilot study will be to assess feasibility of processes as set out in the specific aims.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2017.
- Individual participant dataSharing planned: No
Related trials for Complex Aortic Surgery
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Clinical Outcomes of Patients Treated With Open Surgical Repair for Complex Aortic Aneurysms
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Complex Aortic Surgery, run by The Cleveland Clinic.
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 3 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: finished, as of the sponsor's last update on 7 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary outcome for the pilot study will be to assess feasibility of processes as set out in the specific aims. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Mar 2017.