Severe Aortic StenosisCT-CANCT03291925
Primary Non-invasive Cardiac Computed Tomography Versus Routine Invasive Angiography Prior to TAVI
A study testing Selective invasive angiography based on CT/CCTA imaging. and Procedure/Surgery: Invasive angiography in people with Severe Aortic Stenosis and Transcatheter Aortic Valve Implantation, run by BC Centre for Improved Cardiovascular Health at 1 site in Canada.
Trial summary
This pilot study is a prospective, randomized, open-label trial that aims to assess the feasibility of comparing a primary Computed tomography/Cardiac computed tomography angiography (CT/CCTA) strategy (test arm) to a strategy combining routine use of CT/CCTA and invasive CA (control arm) prior to a Transcatheter… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Severe Aortic Stenosis, Transcatheter Aortic Valve Implantation
- What is being tested?
- Selective invasive angiography based on CT/CCTA imaging. and Procedure/Surgery: Invasive angiography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2016to Sep 2019
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Severe aortic stenosis (Peak transvalvular gradient of ≥ 40mmHg on TTE or stress Echo, Aortic valve area of < 1.0cm2)
- Symptoms suggestive of aortic stenosis (dyspnea, syncope, angina)
- Eligible for TAVI (Upon evaluation by a multidisciplinary team composed of at least one interventional cardiologist and one cardiothoracic surgeon)
Who cannot join
- Severe renal dysfunction Glomerular filtration rate < 30 ml/min.
- Severe left ventricular dysfunction LVEF ≤ 30%
- Recent coronary angiography ≤ 6months from randomization
- Recent PCI ≤ 6months from randomization
- Recent or active acute coronary syndrome (New or worsening angina with or without positive biomarkers or ECG changes).
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
St. Paul's Hospital
Vancouver, British Columbia, V6Z1Y6
Shirley Wong, PhD, 604-682-2344 ext. 65676, 3M@icvhealth.ubc.ca
Leipsic Jonathon, MD
About this study
Official title: Primary Non-invasive Cardiac Computed Tomography Versus Routine Invasive Angiography Prior to TAVI: A Randomized Controlled Pilot Trial (CT-CA Study)
This pilot study is a prospective, randomized, open-label trial that aims to assess the feasibility of comparing a primary Computed tomography/Cardiac computed tomography angiography (CT/CCTA) strategy (test arm) to a strategy combining routine use of CT/CCTA and invasive CA (control arm) prior to a Transcatheter aortic valve implantation (TAVI) procedure. The study will also estimate the rate of composite coronary adverse events (myocardial infarction, post procedural coronary revascularization and cardiovascular mortality) between the two arms at 90 days follow-up. The primary endpoint will be the feasibility of recruitment and compliance with the study protocol at 2 sites in Canada and 1 site in Denmark. Additional clinical endpoints including: all-cause death at 90 days post procedure, myocardial infarction at 90 days post procedure, unplanned PCI or CABG at 90 days post procedure, stroke at 90 days post procedure, CA and PCI related cumulative vascular complications events. This information will be used to inform the design of the definitive efficacy trial.
- Being tested
- Selective invasive angiography based on CT/CCTA imaging., Procedure/Surgery: Invasive angiography
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective invasive angiography based on CT/CCTA imaging.Procedure or surgery
Procedure/Surgery: Invasive angiographyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Selective invasive angiography based on CT/CCTA imaging | Experimental | Patients will undergo selective invasive angiography based on CT/CCTA imaging. Decision to procede with additional invasive CA will be based on adequacy of CT/CCTA evaluation and likelihood of significant coronary artery disease. Receives: Procedure: Selective invasive angiography based on CT/CCTA imaging. |
| Invasive Cardiac Angiography | Active comparator | Patients will undergo systematic invasive angiography. Receives: Procedure: Procedure/Surgery: Invasive angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients enrolled in the study of all those that are eligible
This is the primary outcome for this pilot study to assess feasibility of a larger trial.
Measured: 18 months
Secondary outcomes (7)
All-cause mortality
Measured: 90 days
Myocardial Infarction
According to Valvular Academic Research Consortium-2 (VARC-2) criteria.
- Periprocedural MI (≤72h post procedure).
- Spontaneous MI.
Measured: Peri-procedural (≤72h post procedure) and 90 days
Unplanned revascularization
Any unplanned coronary revascularization either with Percutaneous Coronary Intervention( PCI) or Coronary Artery Bypass Graft (CABG) post TAVI procedure.
Measured: 90 days
Bleeding complication
According to VARC-2 criteria.
- TAVI related ≤ 72h post TAVI
- Coronary procedure related ≤ 72h post CA or PCI (if staged TAVI-PCI)
Measured: Peri-procedural (≤72h post procedure) and 90 days
Device success
According to VARC-2 criteria.
Measured: 90 days
Acute Kidney Injury
According to VARC-2 criteria.
Measured: 90 days
Stroke
An acute episode of focal or global neurological dysfunction caused by the brain, spinal cord, or retinal vascular injury as assessed by a clinician and confirmed by at least one cerebral imaging study (CT or MRI). Stroke may be classified as ischaemic or haemorrhagic
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study startNov 2016
- Primary completionSep 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Aortic StenosisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, open-label trial.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BC Centre for Improved Cardiovascular Health
- Sponsor type
- University, hospital or other
- Collaborators
- Edwards Lifesciences
- Responsible party
- Sponsor
- Investigators
- Jonathon Leipsic, MD, Principal investigator, St. Paul's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03291925
- Sponsor's protocol ID
- ICVHealth2016002
- Acronym
- CT-CA
- Status last verified
- Sep 2017
- First submitted
- 28 Mar 2017
- Last updated
- 25 Sep 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 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Non-invasive Cardiac Computed Tomography Versus Routine Invasive Angiography Prior to TAVI: A Randomized Controlled Pilot Trial (CT-CA Study)
- ClinicalTrials.gov ID
- NCT03291925
- Acronym / sponsor ID
- CT-CA / ICVHealth2016002
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- BC Centre for Improved Cardiovascular HealthUniversity, hospital or other
- Collaborators
- Edwards Lifesciences
- Study start
- Nov 2016
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 25 Sep 2017 (actual)
- 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 pilot study is a prospective, randomized, open-label trial that aims to assess the feasibility of comparing a primary Computed tomography/Cardiac computed tomography angiography (CT/CCTA) strategy (test arm) to a strategy combining routine use of CT/CCTA and invasive CA (control arm) prior to a Transcatheter aortic valve implantation (TAVI) procedure. The study will also estimate the rate of composite coronary adverse events (myocardial infarction, post procedural coronary revascularization and cardiovascular mortality) between the two arms at 90 days follow-up. The primary endpoint will be the feasibility of recruitment and compliance with the study protocol at 2 sites in Canada and 1 site in Denmark. Additional clinical endpoints including: all-cause death at 90 days post procedure, myocardial infarction at 90 days post procedure, unplanned PCI or CABG at 90 days post procedure, stroke at 90 days post procedure, CA and PCI related cumulative vascular complications events. This information will be used to inform the design of the definitive efficacy trial.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, randomized, open-label trial.
| Arm | Type | Receives |
|---|---|---|
| Selective invasive angiography based on CT/CCTA imaging | Experimental | Procedure: Selective invasive angiography based on CT/CCTA imaging.Patients will undergo selective invasive angiography based on CT/CCTA imaging. Decision to procede with additional invasive CA will be based on adequacy of CT/CCTA evaluation and likelihood of significant coronary artery disease. |
| Invasive Cardiac Angiography | Active comparator | Procedure: Procedure/Surgery: Invasive angiographyPatients will undergo systematic invasive angiography. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Severe aortic stenosis (Peak transvalvular gradient of ≥ 40mmHg on TTE or stress Echo, Aortic valve area of < 1.0cm2)
- Symptoms suggestive of aortic stenosis (dyspnea, syncope, angina)
- Eligible for TAVI (Upon evaluation by a multidisciplinary team composed of at least one interventional cardiologist and one cardiothoracic surgeon)
Key exclusion criteria (5 listed)
- Severe renal dysfunction Glomerular filtration rate < 30 ml/min.
- Severe left ventricular dysfunction LVEF ≤ 30%
- Recent coronary angiography ≤ 6months from randomization
- Recent PCI ≤ 6months from randomization
- Recent or active acute coronary syndrome (New or worsening angina with or without positive biomarkers or ECG changes).
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 |
|---|---|---|
| Selective invasive angiography based on CT/CCTA imaging. | Procedure or surgery | Selective invasive angiography based on CT/CCTA imaging |
| Procedure/Surgery: Invasive angiography | Procedure or surgery | Invasive Cardiac Angiography |
Primary outcome
Number of patients enrolled in the study of all those that are eligible
Time frame: 18 months
This is the primary outcome for this pilot study to assess feasibility of a larger trial.
7 secondary outcomes
All-cause mortality
Time frame: 90 days
Myocardial Infarction
Time frame: Peri-procedural (≤72h post procedure) and 90 days
Unplanned revascularization
Time frame: 90 days
Bleeding complication
Time frame: Peri-procedural (≤72h post procedure) and 90 days
Device success
Time frame: 90 days
Acute Kidney Injury
Time frame: 90 days
Stroke
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2017.
- Individual participant dataSharing planned: No
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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.
Jonathon Leipsic, MD principal investigator
St. Paul's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selective invasive angiography based on CT/CCTA imaging. and Procedure/Surgery: Invasive angiography in people with Severe Aortic Stenosis and Transcatheter Aortic Valve Implantation, run by BC Centre for Improved Cardiovascular Health at 1 site in Canada.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 25 Sep 2017. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shirley Wong, PhD (604-682-2344, 3M@icvhealth.ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients enrolled in the study of all those that are eligible (time frame: 18 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 25 Sep 2017.