Low-dose-contrast Cardiac Computed Tomography

NCT02146768 | Completed

• 1 other identifier: 013-234
• Study Type: observational
• Target: 142
• Locations: 1 country
• Sites: 2

Brief Summary

Low-dose-contrast CCTA can effectively and safely assess the aortic valve apparatus, and effectively direct the trans-catheter heart valve (THV) size selection by providing accurate annulus sizing, and provide adequate pre-procedural risk-stratification guidance for TAVR/TAVI.

Conditions

Aortic Stenosis

Outcome Measures

Primary Outcomes (1)

• Number of patients with acute renal failure.

  Compare quality and safety of traditional-dose-contrast CCTA versus low-dose-contrast from a renal standpoint, by using serum creatinine and MDRD - eGFR.

  Baseline (pre and post procedure)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study is a retrospective study of 150 consecutive patients \> 18 years of age (75 patients who received low-dose contrast matched by body mass index with 75 patients who received traditional dose contrast) seen at THHBP between January 1, 2011 and June 30, 2013. Patients with MDRD eGFR \< 25 will be excluded. The cutoff of 25 was chosen as the maximal allowable dose of contrast for eGFR of 25 would be about 90 ml (3.7 x eGFR of 25), and half of that maximal allowable contrast would be 45 ml (the minimum we require to obtain a CCTA with acceptable SNR for post-processing).

You may qualify if:

• \> 18 years of age (75 patients who received low-dose contrast matched by body mass index with 75 patients who received traditional dose contrast) seen at THHBP between January 1, 2011 and June 30, 2013

You may not qualify if:

• Patients with MDRD eGFR \< 25 will be excluded

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (2)

Center for Advance Cardiac Care

Plano, Texas, 75093, United States

Location

The Heart Hospital Baylor Plano

Plano, Texas, 75093, United States

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Ambarish Gopal, MD

  Baylor Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2014
• First Posted: May 26, 2014
• Study Start: January 1, 2014
• Primary Completion: December 1, 2015
• Last Updated: June 12, 2017

Record last verified: 2017-06

Locations

US (2)