CT Perfusion Added to CT Angiography

NCT02773615 | Unknown

• 1 other identifier: S59077
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Background In the differential diagnosis of unstable angina versus non-anginal chest pain, an exercise test is often the modality of choice for further investigation. However, in a substantial number of patients exercise testing is less informative, because of insufficient exercise capacity or pre-existing ECG-abnormalities. In patients with low pretest probability of coronary artery disease (CAD), Coronary CT angiography (CTA) has an excellent negative predictive value, but in patients with an intermediate or high pretest probability of CAD estimation of the hemodynamic significance of a stenosis has only limited specificity. CT perfusion (CTP) is a new method looking at myocardial perfusion during vasodilative stress with a sensitivity, specificity, positive predictive value and negative predictive value of respectively 81%, 93%, 87% and 88%, whereas radiation is limited to a maximum of 5 millisievert (mSv). Aim It is the aim of this pilot study to investigate whether the addition of CTP to CTA is a feasible and safe investigational workflow in patients with unstable angina or nonanginal chest pain in the emergency department.

Conditions

Angina Pectoris

Outcome Measures

Primary Outcomes (1)

• Event free survival

  Registration of adverse cardiac events during clinical follow up

  two years

Secondary Outcomes (3)

• Quality of life

  two years

• Quality of life second

  two years

• Impact of CTP on the diagnostic accuracy for the detection of obstructive CAD

  two years

Interventions

Cardiac computed tomography PROCEDURE

Non-invasive CT scan of the heart

Eligibility Criteria

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

Study Population

Patients presenting in the emergency department with thoracic pain or other symptoms suggestive of angina, will be eligible for the study if there are no ECG-signs of acute ischemia (no STEMI or NSTEMI) and if 2 serial high sensitivity Troponine T measurements with an interval of 1 hour are not conclusive for the diagnosis of ischemia.

You may qualify if:

• Patient presents with chest pain in the ED
• ≥ 18 years of age
• Patient is stable and in adequate clinical condition to undergo CTA + CTP

You may not qualify if:

• no ECG-signs of acute ischemia (no STEMI or NSTEMI)
• Hs Troponine T level/evolution indicative of ischemia
• history of a STEMI or a NSTEMI with residual functional abnormalities
• atrial fibrillation
• renal insufficiency with glomerular filtration rate (GFR) =\< 30 ml/min
• Hb \< 8.5 g/dL
• Infection with systemic involvement
• Baseline respiratory failure requiring oxygen at home
• Severe COPD
• Intrinsic astma

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

University Hospitals Leuven

Leuven, 3000, Belgium

RECRUITING

Related Publications (2)

• Athanasiadis A, Sechtem U; European Society of Cardiology. [Diagnostics and therapy of chronic stable coronary artery disease : new guidelines of the European Society of Cardiology]. Herz. 2014 Dec;39(8):902-12. doi: 10.1007/s00059-014-4159-1. German.

  PMID: 25384852 BACKGROUND

• Williams MC, Newby DE. CT myocardial perfusion imaging: current status and future directions. Clin Radiol. 2016 Aug;71(8):739-49. doi: 10.1016/j.crad.2016.03.006. Epub 2016 Apr 16.

  PMID: 27091433 BACKGROUND

MeSH Terms

Conditions

Angina Pectoris

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kaatje Goetschalckx, MD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kaatje Goetschalckx, MD

CONTACT

+3216344235; kaatje.goetschalckx@uzleuven.be

Steven Dymarkowski, PhD

CONTACT

+3216347766; steven.dymarkowski@uzleuven.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr in Cardiovascular Medicine

Study Record Dates

• First Submitted: May 3, 2016
• First Posted: May 16, 2016
• Study Start: September 28, 2017
• Primary Completion: September 30, 2022
• Study Completion: December 30, 2022
• Last Updated: November 18, 2020

Record last verified: 2020-11

Locations

BE (1)