Recruiting

Cardiac CT vs. Angiography

Sponsor:

BC Centre for Improved Cardiovascular Health

Code:

NCT03291925

Conditions

Severe Aortic Stenosis

Transcatheter Aortic Valve Implantation

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Selective invasive angiography based on CT/CCTA imaging.

Procedure/Surgery: Invasive angiography

Study Details

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.

Conditions

Severe Aortic Stenosis

Transcatheter Aortic Valve Implantation

Study ID

NCT03291925

Start date

Nov, 2016

Status verified date

Sep, 2017

Completion date

Sep, 2019

Anticipated

Primary completion date

Sep, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

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.

active comparator: Invasive Cardiac Angiography

Patients will undergo systematic invasive angiography.

Interventions

Selective invasive angiography based on CT/CCTA imaging.

Procedure/Surgery: Invasive angiography

Primary outcome measure

  • Number of patients enrolled in the study of all those that are eligible [ Time Frame: 18 months ]

Central Contacts and Locations

Central contacts

Shirley Wong, PhD

604-682-23443M@icvhealth.ubc.ca

Locations

St. Paul's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6Z1Y6

Contacts

Shirley Wong, PhD

604-682-23443M@icvhealth.ubc.ca

Principal Investigator:

Leipsic Jonathon, MD

More Information

Sponsor

BC Centre for Improved Cardiovascular Health

Last update posted

Sep 25, 2017

Last verified

Sep, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by BC Centre for Improved Cardiovascular Health on 2017-09-25.