Coronary Artery DiseaseCTP-PRONCT03976921

Impact of Stress CT Myocardial Perfusion on Downstream Resources and Prognosis

A study testing Integration of CCTA with stress CTP when indicated in people with Coronary Artery Disease and Myocardial Ischemia, run by Centro Cardiologico Monzino at 1 site in Italy.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

CT myocardial perfusion imaging (CTP) represents one of the newly developed CT-based techniques but its cost-effectiveness in the clinical pathway is undefined. The aim of the study is to evaluate the usefulness of combined evaluation of coronary anatomy and myocardial perfusion in intermediate to high-risk patients… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Coronary Artery Disease, Myocardial Ischemia
What is being tested?: Integration of CCTA with stress CTP when indicated
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,000 participants
Where: 1 siteItaly
Study dates: 1 Jul 2019to 30 Jun 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

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

Who may be able to join

Consecutive patients (age ≥ 18 years) with known or suspected CAD referred for clinically indicated diagnostic evaluation.
CCTA has to be performed with the state of art in terms of scanner technology as follow: Revolution CT (GE Healthcare, Milwaukee, WI), CardioGraphe (Arineta, Caesarea, Israel), SOMATOM Force (Siemens, Forchheim, Germany), Brilliance iCT and IQon CT (Philips, Best, Netherlands), Aquilion One Vision (Toshiba Medical Systems Corp., Otawara, Japan).

Who cannot join

Performance of any non-invasive diagnostic testing within 90 days before enrollment
Low to intermediate pre-test likelihood of CAD according to the updated Diamond-Forrester risk model score
Acute coronary syndrome
Need for an emergent procedure
Evidence of clinical instability
Contra-indication to contrast agent administration and/or impaired renal function

Show all 12Show fewer

Inability to sustain a breath hold
Pregnancy
Cardiac arrhythmias
Presence of pace maker or implantable cardioverter defibrillator
Contra-indications to the administration of sub-lingual nitrates, beta-blockade and adenosine
Structural cardiomyopathy outside of suspected or know ischemic heart disease

Trial locations and contacts

1 site in 1 country.

Italy1 site

Centro Cardiologico Monzino IRCCS
Milan, MI, 20138

Other trials in Italy

About this study

Official title: Impact of Stress Cardiac Computed Tomography Myocardial Perfusion on Downstream Resources and PROgnosis in Patients With Suspected or Known Coronary Artery Disease: a Multicenter International Study

Read the detailed description

The use of cardiac computed tomography angiography (CCTA) is usually suggested in low to intermediate risk for its diagnostic and prognostic role to rule out CAD with low radiation exposure. In the setting of intermediate to high risk patients, the addition of functional information is prognostically useful and, in patients with previous history of percutaneous coronary intervention (PCI), functional strategy has been shown to be more cost-effective as compared to anatomical assessment CT myocardial perfusion imaging (CTP) represents one of the newly developed CT-based techniques, combining both anatomical and functional evaluation of CAD in a single imaging modality. More recently, stress CTP was shown to provide additional diagnostic value as compared to CCTA alone in intermediate to high risk patients. The purpose of this study will be to evaluate the usefulness and impact of combined evaluation of coronary artery anatomy and myocardial perfusion with CCTA+CTP in intermediate to high risk patients for suspected CAD or with known disease in terms of clinical decision-making, resource utilization, and outcomes in a broad variety of geographic areas and patient subgroups.

CTP-PRO study is a cooperative, international, multicentre, prospective, open-label, randomized controlled study evaluating the cost-effectiveness of a CCTA+CTP strategy versus usual care in intermediate to high risk patients with suspected or known CAD who undergo clinically indicated diagnostic evaluation.

Patients will be screened for study eligibility. Patients meeting all selection criteria will be asked to sign an informed consent document prior to undergoing any study-specific evaluation; then a structured interview will be performed and a clinical history obtained, assessing the presence of common cardiac risk factors, drug therapy (focus on statin, aspirin and/or antiplatelet agent use) and symptoms (typical or atypical angina, to estimate the pre-test likelihood of CAD).

Upon completion of the screening procedure and enrollment, the patients will be randomized 1:1 to the CT-based strategy (Group A) or usual care (Group B). Patient follow-up will be performed at 1 year (± 1 month) and 2 years (± 1 month) by trained interviewers who check medical records or by phone interview collecting the following information: downstream testing; overall radiation exposure; outcomes; cost-effectiveness estimation.

The primary endpoint of the study is the reclassification rate of CCTA in group B due to the addition of CTP. The secondary endpoint will be the comparison between group A and group B in terms of non-invasive and invasive downstream testing, prevalence of obstructive CAD at ICA, revascularization, cumulative ED and overall cost during the follow-up at 1- and 2-years. The tertiary endpoint will be the comparison between each group in terms of MACE and cost-effectiveness at 1- and 2-years.

Conditions: Coronary Artery Disease, Myocardial Ischemia
Being tested: Integration of CCTA with stress CTP when indicated, Standard of care approach
Keywords: Computed Tomography Perfusion, Cardiovascular Outcomes, Cost-effectiveness
Medical subject headings: Coronary Artery Disease, Myocardial Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Integration of CCTA with stress CTP when indicatedDiagnostic test
When judged indicated, functional assessment with stress CTP perfusion will be performed on top of CCTA.
Standard of care approachDiagnostic test
(a) functional non-invasive tests (stress ECG, or imaging-based tests such as Stress Echo, Stress CMR, SPECT or PET) as a gatekeeper for ICA; (b) direct referral to ICA.

Study groups in NCT03976921
Study group	Role	What they receive
CCTA Strategy	Experimental	CCTA will be performed with one of the latest generation scanners. A stenosis > 50% will be considered as significant from an anatomical point of view. For coronary stents, degree of intrastent restenosis will be evaluated by visual assessment of intraluminal contrast density. ISR > 50% will be considered as significant from an anatomical point of view. For CABG, each graft will be visually evaluated and scored as patent, non-significant stenosis ≤ 50%, significant stenosis > 50%, or occluded. For patients with positive CCTA results, additional stress CTP will be performed subsequently. If indicated, vasodilatation will be induced with i.v. adenosine injection or regadenoson. Static or dynamic CTP will be performed according to local practice and scanner technology available. For all patients with previous history of MI the presence of reversible ischemia will be obtained by the comparison between rest and stress perfusion. Receives: Diagnostic Test: Integration of CCTA with stress CTP when indicated
Standard of care Strategy	Active comparator	Patients randomized to this group will be evaluated according to current clinical guidelines with the following approaches: (a) stress ECG, or imaging-based tests such as Stress Echo, Stress CMR, SPECT or PET; (b) direct referral to ICA. Receives: Diagnostic Test: Standard of care approach

What is being measured

The primary outcome is the main question the study is designed to answer.

Reclassification rate of CCTA in group B due to the addition of CTP
For each enrolled patient in whom both CCTA and stress CTP will be performed, the endpoint review committee will use data from coronary CTA and CTP, along with the clinical data to determine the management plan using the following criteria: (a) optimal medical therapy, (b) more non-invasive information required, (c) invasive evaluation required, (d) revascularization treatment (PCI or CABG or hybrid treatment).
Measured: 30 days.

Secondary outcomes (6)

Downstream non-invasive testing
Comparison between group A and group B in terms of number of non-invasive downstream testing (Exercise EKG, Stress-Echo, SPECT, Stress CMR, PET) or invasive testing (invasive coronary angiography) performed after the randomization.
Measured: 1- and 2-years.
Downstream invasive testing
Comparison between group A and group B in terms of number of downstream invasive testing (invasive coronary angiography) performed after the randomization.
Measured: 1- and 2-years.
Prevalence of obstructive CAD at ICA
Comparison between group A and group B in terms of number of patients with obstructive CAD at ICA.
Measured: 1- and 2-years.
Revascularization
Comparison between group A and group B in terms of number of patients treated with revascularization (PCI or CABG or hybrid treatment).
Measured: 1- and 2-years.
Effective Dose
Comparison between group A and group B in terms of cumulative Effective Dose (ED), measured in mSv, due to non-invasive or invasive testing performed after randomization.
Measured: 1- and 2-years.
Overall costs related to downstream diagnostic tests.
Comparison between group A and group B in terms of overall costs of downstream diagnostic tests (sum of costs of all diagnostic tests performed after randomization), expressed in Dollars, according to local reimbursement.
Measured: 1- and 2-years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 201930 Jun 2027

First posted6 Jun 2019
Study start1 Jul 2019
Primary completion30 Jun 2026 (estimated)
Study completion30 Jun 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (34)Papers the sponsor has linked to this study.
Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
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: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Model description: Upon completion of the screening procedure and enrollment, the patients will be randomized 1:1 to the CT-based strategy (Group A) or usual care (Group B).
Masking: None (open label)
Enrolment: 2,000 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03976921
Sponsor's protocol ID: R993/19-CCM 1044
Acronym: CTP-PRO
Status last verified: Jun 2026
First submitted: 30 May 2019
Last updated: 3 Jun 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Budoff MJ, Dowe D, Jollis JG, Gitter M, Sutherland J, Halamert E, Scherer M, Bellinger R, Martin A, Benton R, Delago A, Min JK. Diagnostic performance of 64-multidetector row coronary computed tomographic angiography for evaluation of coronary artery stenosis in individuals without known coronary artery disease: results from the prospective multicenter ACCURACY (Assessment by Coronary Computed Tomographic Angiography of Individuals Undergoing Invasive Coronary Angiography) trial. J Am Coll Cardiol. 2008 Nov 18;52(21):1724-32. doi: 10.1016/j.jacc.2008.07.031.
PubMed 19007693
Pijls NH, Fearon WF, Tonino PA, Siebert U, Ikeno F, Bornschein B, van't Veer M, Klauss V, Manoharan G, Engstrom T, Oldroyd KG, Ver Lee PN, MacCarthy PA, De Bruyne B; FAME Study Investigators. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention in patients with multivessel coronary artery disease: 2-year follow-up of the FAME (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation) study. J Am Coll Cardiol. 2010 Jul 13;56(3):177-84. doi: 10.1016/j.jacc.2010.04.012. Epub 2010 May 28.
PubMed 20537493
Shaw LJ, Berman DS, Maron DJ, Mancini GB, Hayes SW, Hartigan PM, Weintraub WS, O'Rourke RA, Dada M, Spertus JA, Chaitman BR, Friedman J, Slomka P, Heller GV, Germano G, Gosselin G, Berger P, Kostuk WJ, Schwartz RG, Knudtson M, Veledar E, Bates ER, McCallister B, Teo KK, Boden WE; COURAGE Investigators. Optimal medical therapy with or without percutaneous coronary intervention to reduce ischemic burden: results from the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial nuclear substudy. Circulation. 2008 Mar 11;117(10):1283-91. doi: 10.1161/CIRCULATIONAHA.107.743963. Epub 2008 Feb 11.
PubMed 18268144
Task Force Members; Montalescot G, Sechtem U, Achenbach S, Andreotti F, Arden C, Budaj A, Bugiardini R, Crea F, Cuisset T, Di Mario C, Ferreira JR, Gersh BJ, Gitt AK, Hulot JS, Marx N, Opie LH, Pfisterer M, Prescott E, Ruschitzka F, Sabate M, Senior R, Taggart DP, van der Wall EE, Vrints CJ; ESC Committee for Practice Guidelines; Zamorano JL, Achenbach S, Baumgartner H, Bax JJ, Bueno H, Dean V, Deaton C, Erol C, Fagard R, Ferrari R, Hasdai D, Hoes AW, Kirchhof P, Knuuti J, Kolh P, Lancellotti P, Linhart A, Nihoyannopoulos P, Piepoli MF, Ponikowski P, Sirnes PA, Tamargo JL, Tendera M, Torbicki A, Wijns W, Windecker S; Document Reviewers; Knuuti J, Valgimigli M, Bueno H, Claeys MJ, Donner-Banzhoff N, Erol C, Frank H, Funck-Brentano C, Gaemperli O, Gonzalez-Juanatey JR, Hamilos M, Hasdai D, Husted S, James SK, Kervinen K, Kolh P, Kristensen SD, Lancellotti P, Maggioni AP, Piepoli MF, Pries AR, Romeo F, Ryden L, Simoons ML, Sirnes PA, Steg PG, Timmis A, Wijns W, Windecker S, Yildirir A, Zamorano JL. 2013 ESC guidelines on the management of stable coronary artery disease: the Task Force on the management of stable coronary artery disease of the European Society of Cardiology. Eur Heart J. 2013 Oct;34(38):2949-3003. doi: 10.1093/eurheartj/eht296. Epub 2013 Aug 30. No abstract available.
PubMed 23996286
Pontone G, Muscogiuri G, Baggiano A, Andreini D, Guaricci AI, Guglielmo M, Fazzari F, Mushtaq S, Conte E, Annoni A, Formenti A, Mancini E, Verdecchia M, Fusini L, Bonfanti L, Consiglio E, Rabbat MG, Bartorelli AL, Pepi M. Image Quality, Overall Evaluability, and Effective Radiation Dose of Coronary Computed Tomography Angiography With Prospective Electrocardiographic Triggering Plus Intracycle Motion Correction Algorithm in Patients With a Heart Rate Over 65 Beats Per Minute. J Thorac Imaging. 2018 Jul;33(4):225-231. doi: 10.1097/RTI.0000000000000320.
PubMed 29346192
Erthal F, Premaratne M, Yam Y, Chen L, Lamba J, Keenan M, Haddad T, Pharasi K, Anand S, Beanlands RS, Burwash IG, Dwivedi G, Ruddy TD, Chow BJW. Appropriate Use Criteria for Cardiac Computed Tomography: Does Computed Tomography Have Incremental Value in All Appropriate Use Criteria Categories? J Thorac Imaging. 2018 Mar;33(2):132-137. doi: 10.1097/RTI.0000000000000297.
PubMed 28914747
Pontone G, Bertella E, Mushtaq S, Loguercio M, Cortinovis S, Baggiano A, Conte E, Annoni A, Formenti A, Beltrama V, Guaricci AI, Andreini D. Coronary artery disease: diagnostic accuracy of CT coronary angiography--a comparison of high and standard spatial resolution scanning. Radiology. 2014 Jun;271(3):688-94. doi: 10.1148/radiol.13130909. Epub 2014 Feb 8.
PubMed 24520943
Pontone G, Andreini D, Bartorelli AL, Bertella E, Cortinovis S, Mushtaq S, Foti C, Annoni A, Formenti A, Baggiano A, Conte E, Bovis F, Veglia F, Ballerini G, Fiorentini C, Agostoni P, Pepi M. A long-term prognostic value of CT angiography and exercise ECG in patients with suspected CAD. JACC Cardiovasc Imaging. 2013 Jun;6(6):641-50. doi: 10.1016/j.jcmg.2013.01.015.
PubMed 23764093
Pontone G, Andreini D, Guaricci AI, Rota C, Guglielmo M, Mushtaq S, Baggiano A, Beltrama V, Fusini L, Solbiati A, Segurini C, Conte E, Gripari P, Annoni A, Formenti A, Petulla' M, Lombardi F, Muscogiuri G, Bartorelli AL, Pepi M. The STRATEGY Study (Stress Cardiac Magnetic Resonance Versus Computed Tomography Coronary Angiography for the Management of Symptomatic Revascularized Patients): Resources and Outcomes Impact. Circ Cardiovasc Imaging. 2016 Oct;9(10):e005171. doi: 10.1161/CIRCIMAGING.116.005171.
PubMed 27894070
Schuijf JD, Wijns W, Jukema JW, Atsma DE, de Roos A, Lamb HJ, Stokkel MP, Dibbets-Schneider P, Decramer I, De Bondt P, van der Wall EE, Vanhoenacker PK, Bax JJ. Relationship between noninvasive coronary angiography with multi-slice computed tomography and myocardial perfusion imaging. J Am Coll Cardiol. 2006 Dec 19;48(12):2508-14. doi: 10.1016/j.jacc.2006.05.080. Epub 2006 Nov 28.
PubMed 17174190
Takx RA, Blomberg BA, El Aidi H, Habets J, de Jong PA, Nagel E, Hoffmann U, Leiner T. Diagnostic accuracy of stress myocardial perfusion imaging compared to invasive coronary angiography with fractional flow reserve meta-analysis. Circ Cardiovasc Imaging. 2015 Jan;8(1):e002666. doi: 10.1161/CIRCIMAGING.114.002666.
PubMed 25596143
Yang Z, Zheng H, Zhou T, Yang LF, Hu XF, Peng ZH, Jiang YZ, Li M, Sun G. Diagnostic performance of myocardial perfusion imaging with SPECT, CT and MR compared to fractional flow reserve as reference standard. Int J Cardiol. 2015;190:103-5. doi: 10.1016/j.ijcard.2015.04.091. Epub 2015 Apr 15. No abstract available.
PubMed 25920018
Pontone G, Andreini D, Guaricci AI, Baggiano A, Fazzari F, Guglielmo M, Muscogiuri G, Berzovini CM, Pasquini A, Mushtaq S, Conte E, Calligaris G, De Martini S, Ferrari C, Galli S, Grancini L, Ravagnani P, Teruzzi G, Trabattoni D, Fabbiocchi F, Lualdi A, Montorsi P, Rabbat MG, Bartorelli AL, Pepi M. Incremental Diagnostic Value of Stress Computed Tomography Myocardial Perfusion With Whole-Heart Coverage CT Scanner in Intermediate- to High-Risk Symptomatic Patients Suspected of Coronary Artery Disease. JACC Cardiovasc Imaging. 2019 Feb;12(2):338-349. doi: 10.1016/j.jcmg.2017.10.025. Epub 2018 Feb 14.
PubMed 29454774
Pontone G, Andreini D, Guaricci AI, Guglielmo M, Baggiano A, Muscogiuri G, Fusini L, Soldi M, Fazzari F, Berzovini C, Pasquini A, Ciancarella P, Mushtaq S, Conte E, Calligaris G, De Martini S, Ferrari C, Galli S, Grancini L, Ravagnani P, Teruzzi G, Trabattoni D, Fabbiocchi F, Lualdi A, Montorsi P, Rabbat MG, Bartorelli AL, Pepi M. Quantitative vs. qualitative evaluation of static stress computed tomography perfusion to detect haemodynamically significant coronary artery disease. Eur Heart J Cardiovasc Imaging. 2018 Nov 1;19(11):1244-1252. doi: 10.1093/ehjci/jey111.
PubMed 30107557
Jensen JM, Voss M, Hansen VB, Andersen LK, Johansen PB, Munkholm H, Norgaard BL. Risk stratification of patients suspected of coronary artery disease: comparison of five different models. Atherosclerosis. 2012 Feb;220(2):557-62. doi: 10.1016/j.atherosclerosis.2011.11.027. Epub 2011 Nov 25.
PubMed 22189201

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of Stress Cardiac Computed Tomography Myocardial Perfusion on Downstream Resources and PROgnosis in Patients With Suspected or Known Coronary Artery Disease: a Multicenter International Study
ClinicalTrials.gov ID: NCT03976921
Acronym / sponsor ID: CTP-PRO / R993/19-CCM 1044
Conditions: Coronary Artery Disease, Myocardial Ischemia
Keywords: Computed Tomography Perfusion, Cardiovascular Outcomes, Cost-effectiveness
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 2,000 participants (estimated)
Lead sponsor: Centro Cardiologico MonzinoUniversity, hospital or other
Collaborators: Semmelweis University Heart and Vascular Center, Emory University, Johns Hopkins University, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Vall d'Hebron Institute Research, Humanitas Research Hospital IRCCS, Rozzano-Milan, Ospedale Polispecialistico Humanitas Gavazzeni, Bergamo, IRCCS San Raffaele, Mayo Clinic, Istituto Auxologico Italiano - IRCCS - Ospedale San Luca - Milano, A.O.U. Città della Salute e della Scienza - Molinette Hospital
Study start: 1 Jul 2019 (actual)
Primary completion: 30 Jun 2026 (estimated)
Study completion: 30 Jun 2027 (estimated)
First posted: 6 Jun 2019 (actual)
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.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Upon completion of the screening procedure and enrollment, the patients will be randomized 1:1 to the CT-based strategy (Group A) or usual care (Group B).

Arm	Type	Receives
CCTA Strategy	Experimental	Diagnostic Test: Integration of CCTA with stress CTP when indicatedCCTA will be performed with one of the latest generation scanners. A stenosis > 50% will be considered as significant from an anatomical point of view. For coronary stents, degree of intrastent restenosis will be evaluated by visual assessment of intraluminal contrast density. ISR > 50% will be considered as significant from an anatomical point of view. For CABG, each graft will be visually evaluated and scored as patent, non-significant stenosis ≤ 50%, significant stenosis > 50%, or occluded. For patients with positive CCTA results, additional stress CTP will be performed subsequently. If indicated, vasodilatation will be induced with i.v. adenosine injection or regadenoson. Static or dynamic CTP will be performed according to local practice and scanner technology available. For all patients with previous history of MI the presence of reversible ischemia will be obtained by the comparison between rest and stress perfusion.
Standard of care Strategy	Active comparator	Diagnostic Test: Standard of care approachPatients randomized to this group will be evaluated according to current clinical guidelines with the following approaches: (a) stress ECG, or imaging-based tests such as Stress Echo, Stress CMR, SPECT or PET; (b) direct referral to ICA.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Consecutive patients (age ≥ 18 years) with known or suspected CAD referred for clinically indicated diagnostic evaluation.
CCTA has to be performed with the state of art in terms of scanner technology as follow: Revolution CT (GE Healthcare, Milwaukee, WI), CardioGraphe (Arineta, Caesarea, Israel), SOMATOM Force (Siemens, Forchheim, Germany), Brilliance iCT and IQon CT (Philips, Best, Netherlands), Aquilion One Vision (Toshiba Medical Systems Corp., Otawara, Japan).

Key exclusion criteria (12 listed)

Performance of any non-invasive diagnostic testing within 90 days before enrollment
Low to intermediate pre-test likelihood of CAD according to the updated Diamond-Forrester risk model score
Acute coronary syndrome
Need for an emergent procedure
Evidence of clinical instability

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
Integration of CCTA with stress CTP when indicatedWhen judged indicated, functional assessment with stress CTP perfusion will be performed on top of CCTA.	Diagnostic test	CCTA Strategy
Standard of care approach(a) functional non-invasive tests (stress ECG, or imaging-based tests such as Stress Echo, Stress CMR, SPECT or PET) as a gatekeeper for ICA; (b) direct referral to ICA.	Diagnostic test	Standard of care Strategy

Primary outcome

Reclassification rate of CCTA in group B due to the addition of CTP
Time frame: 30 days.
For each enrolled patient in whom both CCTA and stress CTP will be performed, the endpoint review committee will use data from coronary CTA and CTP, along with the clinical data to determine the management plan using the following criteria: (a) optimal medical therapy, (b) more non-invasive information required, (c) invasive evaluation required, (d) revascularization treatment (PCI or CABG or hybrid treatment).

6 secondary outcomes

Downstream non-invasive testing
Time frame: 1- and 2-years.
Downstream invasive testing
Time frame: 1- and 2-years.
Prevalence of obstructive CAD at ICA
Time frame: 1- and 2-years.
Revascularization
Time frame: 1- and 2-years.
Effective Dose
Time frame: 1- and 2-years.
Overall costs related to downstream diagnostic tests.
Time frame: 1- and 2-years.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
Background: PubMed 19007693Budoff MJ, Dowe D, Jollis JG, Gitter M, Sutherland J, Halamert E, Scherer M, Bellinger R, Martin A, Benton R, Delago A, Min JK. Diagnostic performance of 64-multidetector row coronary computed tomographic angiography for evaluation of coronary artery stenosis in individuals without known coronary artery disease: results from the prospective multicenter ACCURACY (Assessment by Coronary Computed Tomographic Angiography of Individuals Undergoing Invasive Coronary Angiography) trial. J Am Coll Cardiol. 2008 Nov 18;52(21):1724-32. doi: 10.1016/j.jacc.2008.07.031.
Background: PubMed 20537493Pijls NH, Fearon WF, Tonino PA, Siebert U, Ikeno F, Bornschein B, van't Veer M, Klauss V, Manoharan G, Engstrom T, Oldroyd KG, Ver Lee PN, MacCarthy PA, De Bruyne B; FAME Study Investigators. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention in patients with multivessel coronary artery disease: 2-year follow-up of the FAME (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation) study. J Am Coll Cardiol. 2010 Jul 13;56(3):177-84. doi: 10.1016/j.jacc.2010.04.012. Epub 2010 May 28.
Background: PubMed 18268144Shaw LJ, Berman DS, Maron DJ, Mancini GB, Hayes SW, Hartigan PM, Weintraub WS, O'Rourke RA, Dada M, Spertus JA, Chaitman BR, Friedman J, Slomka P, Heller GV, Germano G, Gosselin G, Berger P, Kostuk WJ, Schwartz RG, Knudtson M, Veledar E, Bates ER, McCallister B, Teo KK, Boden WE; COURAGE Investigators. Optimal medical therapy with or without percutaneous coronary intervention to reduce ischemic burden: results from the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial nuclear substudy. Circulation. 2008 Mar 11;117(10):1283-91. doi: 10.1161/CIRCULATIONAHA.107.743963. Epub 2008 Feb 11.
Background: PubMed 23996286Task Force Members; Montalescot G, Sechtem U, Achenbach S, Andreotti F, Arden C, Budaj A, Bugiardini R, Crea F, Cuisset T, Di Mario C, Ferreira JR, Gersh BJ, Gitt AK, Hulot JS, Marx N, Opie LH, Pfisterer M, Prescott E, Ruschitzka F, Sabate M, Senior R, Taggart DP, van der Wall EE, Vrints CJ; ESC Committee for Practice Guidelines; Zamorano JL, Achenbach S, Baumgartner H, Bax JJ, Bueno H, Dean V, Deaton C, Erol C, Fagard R, Ferrari R, Hasdai D, Hoes AW, Kirchhof P, Knuuti J, Kolh P, Lancellotti P, Linhart A, Nihoyannopoulos P, Piepoli MF, Ponikowski P, Sirnes PA, Tamargo JL, Tendera M, Torbicki A, Wijns W, Windecker S; Document Reviewers; Knuuti J, Valgimigli M, Bueno H, Claeys MJ, Donner-Banzhoff N, Erol C, Frank H, Funck-Brentano C, Gaemperli O, Gonzalez-Juanatey JR, Hamilos M, Hasdai D, Husted S, James SK, Kervinen K, Kolh P, Kristensen SD, Lancellotti P, Maggioni AP, Piepoli MF, Pries AR, Romeo F, Ryden L, Simoons ML, Sirnes PA, Steg PG, Timmis A, Wijns W, Windecker S, Yildirir A, Zamorano JL. 2013 ESC guidelines on the management of stable coronary artery disease: the Task Force on the management of stable coronary artery disease of the European Society of Cardiology. Eur Heart J. 2013 Oct;34(38):2949-3003. doi: 10.1093/eurheartj/eht296. Epub 2013 Aug 30. No abstract available.
Background: PubMed 29346192Pontone G, Muscogiuri G, Baggiano A, Andreini D, Guaricci AI, Guglielmo M, Fazzari F, Mushtaq S, Conte E, Annoni A, Formenti A, Mancini E, Verdecchia M, Fusini L, Bonfanti L, Consiglio E, Rabbat MG, Bartorelli AL, Pepi M. Image Quality, Overall Evaluability, and Effective Radiation Dose of Coronary Computed Tomography Angiography With Prospective Electrocardiographic Triggering Plus Intracycle Motion Correction Algorithm in Patients With a Heart Rate Over 65 Beats Per Minute. J Thorac Imaging. 2018 Jul;33(4):225-231. doi: 10.1097/RTI.0000000000000320.
Background: PubMed 28914747Erthal F, Premaratne M, Yam Y, Chen L, Lamba J, Keenan M, Haddad T, Pharasi K, Anand S, Beanlands RS, Burwash IG, Dwivedi G, Ruddy TD, Chow BJW. Appropriate Use Criteria for Cardiac Computed Tomography: Does Computed Tomography Have Incremental Value in All Appropriate Use Criteria Categories? J Thorac Imaging. 2018 Mar;33(2):132-137. doi: 10.1097/RTI.0000000000000297.
Background: PubMed 24520943Pontone G, Bertella E, Mushtaq S, Loguercio M, Cortinovis S, Baggiano A, Conte E, Annoni A, Formenti A, Beltrama V, Guaricci AI, Andreini D. Coronary artery disease: diagnostic accuracy of CT coronary angiography--a comparison of high and standard spatial resolution scanning. Radiology. 2014 Jun;271(3):688-94. doi: 10.1148/radiol.13130909. Epub 2014 Feb 8.
Background: PubMed 23764093Pontone G, Andreini D, Bartorelli AL, Bertella E, Cortinovis S, Mushtaq S, Foti C, Annoni A, Formenti A, Baggiano A, Conte E, Bovis F, Veglia F, Ballerini G, Fiorentini C, Agostoni P, Pepi M. A long-term prognostic value of CT angiography and exercise ECG in patients with suspected CAD. JACC Cardiovasc Imaging. 2013 Jun;6(6):641-50. doi: 10.1016/j.jcmg.2013.01.015.
Background: PubMed 27894070Pontone G, Andreini D, Guaricci AI, Rota C, Guglielmo M, Mushtaq S, Baggiano A, Beltrama V, Fusini L, Solbiati A, Segurini C, Conte E, Gripari P, Annoni A, Formenti A, Petulla' M, Lombardi F, Muscogiuri G, Bartorelli AL, Pepi M. The STRATEGY Study (Stress Cardiac Magnetic Resonance Versus Computed Tomography Coronary Angiography for the Management of Symptomatic Revascularized Patients): Resources and Outcomes Impact. Circ Cardiovasc Imaging. 2016 Oct;9(10):e005171. doi: 10.1161/CIRCIMAGING.116.005171.
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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.

Gianluca Pontone, MD, PhD principal investigator

Centro Cardiologico Monzino, IRCCS

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Integration of CCTA with stress CTP when indicated in people with Coronary Artery Disease and Myocardial Ischemia, run by Centro Cardiologico Monzino at 1 site in Italy.

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 2 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 3 Jun 2026. 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 Italy. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reclassification rate of CCTA in group B due to the addition of CTP (time frame: 30 days.). 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 NCT03976921, which also lists 34 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 3 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.