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CT Perfusion Added to CT Angiography (PERFeCT)

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ClinicalTrials.gov Identifier: NCT02773615
Recruitment Status : Recruiting
First Posted : May 16, 2016
Last Update Posted : November 18, 2020
Sponsor:
Information provided by (Responsible Party):
dr. Kaatje Goetschalckx, Universitaire Ziekenhuizen Leuven

Study Description
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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.


Condition or disease Intervention/treatment
Angina Pectoris Procedure: Cardiac computed tomography

Detailed Description:

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.

Methods 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 Troponin T measurements with an interval of 1 hour are not conclusive for the diagnosis of ischemia.

Exclusion criteria are a history of a STEMI or a NSTEMI with residual functional abnormalities, atrial fibrillation, renal insufficiency with glomerular filtration rate (GFR) < 60 ml/min or known contrast allergy. A number of 100 patients in one year is targeted.

A pretest-probability score is calculated based on age, gender and type of angina of the patient. Typical angina is defined as substernal chest pain or discomfort provoked by exertion or emotional stress and relieved by rest or nitrates within minutes, atypical angina meets 2 of the 3 characteristics and nonanginal pain meets one or none of the characteristics. The time point of admission in the emergency department is recorded.(cf. Figure 1) Patients will undergo a CT (Siemens Somatom Force) with calcium-scoring and CT angiography (CTA). The amount of contrast used is about 60 ml, and the radiation varies between 0.5 and 1.5 mSv. If the CTA is completely normal and Ca-scoring is low (< 100), no further investigations are performed and the diagnosis of nonanginal pain is probable. Patients are dismissed from the emergency ward with follow-up organized for one year. Cf. Figure 2.

If there are abnormalities on CTA, or if there is a elevated Ca-scoring (> 300), even in the absence of stenosis on CTA, a CT perfusion sequence is added during dipyridamole stress. The amount of contrast used for CTP is about 50 ml and the radiation used for CTP varies between 3 to 4 mSv, resulting in a total radiation dose of less than 5 mSv. Dipyridamole is administered in a dose of 140 µg/kg body weight/minute during 6 minutes through a peripheral vein. CTP is performed 2 minutes after completion of the dipyridamole infusion.

If CTP is suggestive of cardiac ischemia, defined as a visual perfusion defect, an invasive coronary angiography, with fractional flow measurement if needed, will be performed.

If CTP is negative, defined as no visual perfusion defect, no further investigations are performed and the diagnosis of nonanginal pain is probable. Patients are dismissed from the emergency ward with follow-up for one year. Cf. Figure 2.

At dismissal, patients are asked to fill in an angina-questionnaire (short form Seattle Angina Questionnaire, SAQ) , a quality of life (SF-12 Health Survey) , and a satisfaction questionnaire about the hospital stay and investigational flow). The time point of dismissal is recorded.

After dismissal, patients are contacted after 3 months to ask for hospitalizations or investigations that might have occurred in the mean time, and to fill in the same SAQ and SF-12. At 12 months after the initial presentation, patients are invited to a cardiac consultation and questionnaires are completed for the last time.

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: CT Perfusion Added to CT Angiography for Unstable Angina or Nonanginal Chest Pain in the Emergency Department (PERFeCT) : a Feasibility and Safety Pilot Study.
Actual Study Start Date : September 28, 2017
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina Chest Pain

Groups and Cohorts
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Intervention Details:
  • Procedure: Cardiac computed tomography
    Non-invasive CT scan of the heart

Outcome Measures
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Primary Outcome Measures :
  1. Event free survival [ Time Frame: two years ]
    Registration of adverse cardiac events during clinical follow up


Secondary Outcome Measures :
  1. Quality of life [ Time Frame: two years ]
    Assessment of quality of life using the Seattle Angina Questionnaire (SAQ7)

  2. Quality of life second [ Time Frame: two years ]
    Quality-of-life (SF-12 health survey) questionnaire.

  3. Impact of CTP on the diagnostic accuracy for the detection of obstructive CAD [ Time Frame: two years ]
    Evaluated according to pre test probability


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02773615


Contacts
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Contact: Kaatje Goetschalckx, MD +3216344235 kaatje.goetschalckx@uzleuven.be
Contact: Steven Dymarkowski, PhD +3216347766 steven.dymarkowski@uzleuven.be

Locations
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Belgium
University Hospitals Leuven Recruiting
Leuven, Belgium, 3000
Contact: Stefan Janssens, MD, PhD    +3216344235    stefan.janssens@uzleuven.be   
Principal Investigator: Kaatje Goetschalckx, MD         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
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Principal Investigator: Kaatje Goetschalckx, MD UZ Leuven
More Information
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Additional Information:

Publications:

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Responsible Party: dr. Kaatje Goetschalckx, Dr in Cardiovascular Medicine, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02773615    
Other Study ID Numbers: S59077
First Posted: May 16, 2016    Key Record Dates
Last Update Posted: November 18, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
 Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations