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CT-CA: Primary Non-invasive Cardiac Computed Tomography Versus Routine Invasive Angiography Prior to TAVI

Sponsor
BC Centre for Improved Cardiovascular Health (Other)
Overall Status
Unknown status
CT.gov ID
NCT03291925
Collaborator
Edwards Lifesciences (Industry)
200
Enrollment
1
Location
2
Arms
34
Duration (Months)
5.9
Patients Per Site Per Month

Study Details

Study Description

Brief 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 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Selective invasive angiography based on CT/CCTA imaging.
  • Procedure: Procedure/Surgery: Invasive angiography
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Prospective, randomized, open-label trial.Prospective, randomized, open-label trial.
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Primary Non-invasive Cardiac Computed Tomography Versus Routine Invasive Angiography Prior to TAVI: A Randomized Controlled Pilot Trial (CT-CA Study)
Study Start Date :
Nov 1, 2016
Anticipated Primary Completion Date :
Sep 1, 2019
Anticipated Study Completion Date :
Sep 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Procedure: Selective invasive angiography based on CT/CCTA imaging.
Active Comparator: Invasive Cardiac Angiography

Patients will undergo systematic invasive angiography.

Procedure: Procedure/Surgery: Invasive angiography

Outcome Measures

Primary Outcome Measures

  1. Number of patients enrolled in the study of all those that are eligible [18 months]

    This is the primary outcome for this pilot study to assess feasibility of a larger trial.

Secondary Outcome Measures

  1. All-cause mortality [90 days]

  2. Myocardial Infarction [Peri-procedural (≤72h post procedure) and 90 days]

    According to Valvular Academic Research Consortium-2 (VARC-2) criteria. Periprocedural MI (≤72h post procedure). Spontaneous MI.

  3. Unplanned revascularization [90 days]

    Any unplanned coronary revascularization either with Percutaneous Coronary Intervention( PCI) or Coronary Artery Bypass Graft (CABG) post TAVI procedure.

  4. Bleeding complication [Peri-procedural (≤72h post procedure) and 90 days]

    According to VARC-2 criteria. TAVI related ≤ 72h post TAVI Coronary procedure related ≤ 72h post CA or PCI (if staged TAVI-PCI)

  5. Device success [90 days]

    According to VARC-2 criteria.

  6. Acute Kidney Injury [90 days]

    According to VARC-2 criteria.

  7. Stroke [90 days]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 St. Paul's Hospital Vancouver British Columbia Canada V6Z1Y6

Sponsors and Collaborators

  • BC Centre for Improved Cardiovascular Health
  • Edwards Lifesciences

Investigators

  • Principal Investigator: Jonathon Leipsic, MD, St. Paul's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
BC Centre for Improved Cardiovascular Health
ClinicalTrials.gov Identifier:
NCT03291925
Other Study ID Numbers:
  • ICVHealth2016002
First Posted:
Sep 25, 2017
Last Update Posted:
Sep 25, 2017
Last Verified:
Sep 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:
Aortic Valve Stenosis

Study Results

No Results Posted as of Sep 25, 2017