Angina PectorisPERFeCTNCT02773615
CT Perfusion Added to CT Angiography
An observational study of Angina Pectoris, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angina Pectoris
- What is being tested?
- Cardiac computed tomography
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteBelgium
- Study dates
- 28 Sep 2017to 30 Dec 2022
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patient presents with chest pain in the ED
- ≥ 18 years of age
- Patient is stable and in adequate clinical condition to undergo CTA + CTP
Who cannot join
- 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
Show all 10Show fewer
- Infection with systemic involvement
- Baseline respiratory failure requiring oxygen at home
- Severe COPD
- Intrinsic astma
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
University Hospitals Leuven
Leuven, 3000
Stefan Janssens, MD, PhD, +3216344235, stefan.janssens@uzleuven.be
Kaatje Goetschalckx, MD
About this study
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.
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.
Read the 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.
- Conditions
- Angina Pectoris
- Being tested
- Cardiac computed tomography
- Medical subject headings
- Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac computed tomographyProcedure or surgery
Non-invasive CT scan of the heart
What is being measured
The primary outcome is the main question the study is designed to answer.
Event free survival
Registration of adverse cardiac events during clinical follow up
Measured: two years
Secondary outcomes (3)
Quality of life
Assessment of quality of life using the Seattle Angina Questionnaire (SAQ7)
Measured: two years
Quality of life second
Quality-of-life (SF-12 health survey) questionnaire.
Measured: two years
Impact of CTP on the diagnostic accuracy for the detection of obstructive CAD
Evaluated according to pre test probability
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2016 (estimated)
- Study start28 Sep 2017
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Angina PectorisStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr. Kaatje Goetschalckx, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Kaatje Goetschalckx, MD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02773615
- Sponsor's protocol ID
- S59077
- Acronym
- PERFeCT
- Status last verified
- Nov 2020
- First submitted
- 3 May 2016
- Last updated
- 18 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 25384852Williams 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.
PubMed 27091433
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02773615
- Acronym / sponsor ID
- PERFeCT / S59077
- Conditions
- Angina Pectoris
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 28 Sep 2017 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 16 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Patient presents with chest pain in the ED
- ≥ 18 years of age
- Patient is stable and in adequate clinical condition to undergo CTA + CTP
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac computed tomographyNon-invasive CT scan of the heart | Procedure or surgery | – |
Primary outcome
Event free survival
Time frame: two years
Registration of adverse cardiac events during clinical follow up
3 secondary outcomes
Quality of life
Time frame: two years
Quality of life second
Time frame: two years
Impact of CTP on the diagnostic accuracy for the detection of obstructive CAD
Time frame: two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2020.
- Background: PubMed 25384852Athanasiadis 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.
- Background: PubMed 27091433Williams 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kaatje Goetschalckx, MD principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Angina Pectoris, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kaatje Goetschalckx, MD (+3216344235, kaatje.goetschalckx@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event free survival (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02773615, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2020.