Coronary Artery DiseasePhase 3NCT01368770
Stress Testing Compared to Coronary Computed Tomographic Angiography in Patients With Suspected Coronary Artery Disease
A Phase 3 study testing Coronary CTA and Stress MPI SPECT in people with Coronary Artery Disease, run by All India Institute of Medical Sciences at 1 site in India.
Trial summary
The use of coronary computed tomographic angiography(CTA)is rapidly increasing, but there is lack of data which supports their use in the initial evaluation of patients who are asymptomatic or mildly symptomatic. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Coronary CTA and Stress MPI SPECT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 303 participants
- Where
- 1 siteIndia
- Study dates
- Jul 2011to Dec 2014
- Phase
- Phase 3
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consenting patients above 21 years who are mildly symptomatic (those in class II NYHA), who have an intermediate likelihood of CAD, or asymptomatic patients who are determined to be at intermediate or high risk of coronary events by the Framingham (ATP III) criteria
Who cannot join
- Patients with prior documented CAD (by angiography), MI, coronary stenting or bypass surgery
- Patients in class III or IV NYHA
- Patients with chronic renal impairment to the extent of precluding contrast injection
- Severe medical disease with limited expectancy of life
- Contra-indication or allergy to pharmacologic stress agents or contrast agents
- Patients with unstable cardiac rhythms (including persistent atrial fibrillation) which preclude good ECG gating
- Weight limitations due to scanner design
- Pregnant/ lactating women
Trial locations and contacts
1 site in 1 country.
India1 site
Department of cardiology, All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, 110029
About this study
Official title: Stress-rest Single Photon-Emission Computed Tomography(SPECT)Compared to Coronary Computed Tomographic Angiography in the Initial Evaluation of Patients With Suspected Coronary Artery Disease-A Pilot Randomized Controlled Trial
The use of coronary computed tomographic angiography(CTA)is rapidly increasing, but there is lack of data which supports their use in the initial evaluation of patients who are asymptomatic or mildly symptomatic. The hypothesis underlying this proposal is that the use of stress-rest myocardial perfusion imaging (MPI) as an initial test for the evaluation of asymptomatic or mildly symptomatic patients who are at intermediate risk of coronary events will result in less further non-invasive and invasive testing and result in reduced costs, without adversely affecting clinical outcomes in the short term.
Read the detailed description
Recently coronary computed tomographic angiography (CTA) has become increasingly popular as a means of investigating asymptomatic or mildly symptomatic patients, instead of stress-rest myocardial perfusion imaging (MPI), despite the absence of long-term prognostic data. With its high negative predictive value, CTA has become useful for exclusion of CAD in patients with chest pain syndromes. However, the clinical management of a patient with an abnormal CTA is not well defined. Further, several caveats remain regarding the use of coronary CTA. Despite the anatomic data provided by CTA, it does not yield information regarding the functional consequences of the obstruction. Moreover, this technique may miss small vessel disease because of limited resolution and may not be useful in the presence of significant vessel calcium or coronary stents. Most importantly, there is no long-term data regarding the prognostic ability of coronary CTA in the initial evaluation of patients at intermediate risk of coronary events. An abnormal CTA result often leads to additional functional testing or invasive coronary angiography. The major drawback of performing two or more tests in tandem is that it greatly adds to cost that can be prohibitive in lower and middle income countries. Therefore, there is a need to determine if either stress MPI or CTA performed initially, results in meaningful differences in costs without adversely affecting clinical outcomes.
The primary objective of this pilot study is to compare the efficacy (in terms of reduced additional non-invasive or invasive testing) and costs of a strategy of initial stress-rest MPI, to a strategy of initial coronary CTA in the management of asymptomatic or mildly symptomatic patients who are at intermediate risk of coronary events (death or nonfatal MI) by the Framingham criteria.
- Conditions
- Coronary Artery Disease
- Being tested
- Coronary CTA, Stress MPI SPECT
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary CTAOther
Coronary CTA using standard protocols
Stress MPI SPECTOther
Stress MPI using standard protocols
| Study group | Role | What they receive |
|---|---|---|
| Coronary CTA | Experimental | Coronary CTA using standard protocols Receives: Other: Coronary CTA; Other: Stress MPI SPECT |
| Stress MPI SPECT | Active comparator | Stress-rest MPI SPECT using standard protocols Receives: Other: Coronary CTA; Other: Stress MPI SPECT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who have additional non-invasive testing with another modality, or invasive coronary angiography within 6 months of the first test.
The primary objective is to compare the efficacy (in terms of reduced additional non-invasive or invasive testing) and costs (at 6 months) of a strategy of initial stress-rest MPI, to a strategy of initial coronary CTA in the management of asymptomatic patients at intermediate or high risk of coronary events by the Framingham criteria, or mildly symptomatic patients who are at intermediate likelihood of having CAD.
Measured: 6 months
Costs of investigation and treatment in both groups
To compare costs between a strategy of initial stress-rest MPI with a strategy of initial coronary CTA in the management of asymptomatic patients at intermediate or high risk of coronary events by the Framingham criteria, or mildly symptomatic patients who are at intermediate likelihood of having CAD.
Measured: 6 months
Secondary outcomes (1)
Proportion of patients who have planned, elective invasive angiography, elective coronary revascularization, or MACE at 6 month and at 1-year follow up
To compare these two strategies in terms of the incidence of planned coronary angiography, revascularization and adverse clinical outcomes at 1 year (death, nonfatal MI, recurrent ischemia or unplanned coronary revascularization)
Measured: 6 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2011 (estimated)
- Study startJul 2011
- Primary completionJun 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Bab El Oued, Hospital Italiano Garibaldi,Rosario ARGENTINA, Pontificia Universidad Catolica de Chile, Fu Wai Hospital, Beijing, China, Instituto de Cardiologia,Bogota D.C. COLOMBIA, Instituto de Cardiologia y Cirugia Cardiovascular,LA Habana CUBA, University Hospital Ostrava, Indian Institute of Public Health, India, Università degli Studi di Brescia, Universidad Nacional Autonoma de Mexico, University Medical Centre Ljubljana, Ankara University, International Atomic Energy Agency
- Responsible party
- Principal investigator, Dr Ganesan Karthikeyan, All India Institute of Medical Sciences
- Investigators
- Ganesan Karthikeyan, MD,DM,MSc, Principal investigator, All India Institute of Medical SciencesSalah E Bouyoucef, Principal investigator, Centre Hospitalier Universitaire de Bab El-QuedJorge Cachero, Principal investigator, Hospital Italiano GaribaldiRodrigo J Fernández, Principal investigator, Universidad Católica de ChileZuo X He, Principal investigator, Fu Wai Hospital, Beijing, ChinaClaudia Teresa G Villamil, Principal investigator, Instituto de CardiologiaAmalia T Peix González, Principal investigator, Instituto de Cardiologia y Cirugia CardiovascularOtakar Kraft, Principal investigator, University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01368770
- Sponsor's protocol ID
- Protocol version 1.1
- Other IDs
- CTRI/2010/091/001384
- Status last verified
- Apr 2015
- First submitted
- 6 Jun 2011
- Last updated
- 2 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Karthikeyan G, Guzic Salobir B, Jug B, Devasenapathy N, Alexanderson E, Vitola J, Kraft O, Ozkan E, Sharma S, Purohit G, Dolenc Novak M, Meave A, Trevethan S, Cerci R, Zier S, Gotthardtova L, Jonszta T, Altin T, Soydal C, Patel C, Gulati G, Paez D, Dondi M, Kashyap R. Functional compared to anatomical imaging in the initial evaluation of patients with suspected coronary artery disease: An international, multi-center, randomized controlled trial (IAEA-SPECT/CTA study). J Nucl Cardiol. 2017 Apr;24(2):507-517. doi: 10.1007/s12350-016-0664-3. Epub 2016 Oct 28.
PubMed 27796852
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress-rest Single Photon-Emission Computed Tomography(SPECT)Compared to Coronary Computed Tomographic Angiography in the Initial Evaluation of Patients With Suspected Coronary Artery Disease-A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01368770
- Acronym / sponsor ID
- Protocol version 1.1
- Conditions
- Coronary Artery Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Bab El Oued, Hospital Italiano Garibaldi,Rosario ARGENTINA, Pontificia Universidad Catolica de Chile, Fu Wai Hospital, Beijing, China, Instituto de Cardiologia,Bogota D.C. COLOMBIA, Instituto de Cardiologia y Cirugia Cardiovascular,LA Habana CUBA, University Hospital Ostrava, Indian Institute of Public Health, India, Università degli Studi di Brescia, Universidad Nacional Autonoma de Mexico, University Medical Centre Ljubljana, Ankara University, International Atomic Energy Agency
- Study start
- Jul 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 8 Jun 2011 (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.
The use of coronary computed tomographic angiography(CTA)is rapidly increasing, but there is lack of data which supports their use in the initial evaluation of patients who are asymptomatic or mildly symptomatic. The hypothesis underlying this proposal is that the use of stress-rest myocardial perfusion imaging (MPI) as an initial test for the evaluation of asymptomatic or mildly symptomatic patients who are at intermediate risk of coronary events will result in less further non-invasive and invasive testing and result in reduced costs, without adversely affecting clinical outcomes in the short term.
Detailed description
Recently coronary computed tomographic angiography (CTA) has become increasingly popular as a means of investigating asymptomatic or mildly symptomatic patients, instead of stress-rest myocardial perfusion imaging (MPI), despite the absence of long-term prognostic data. With its high negative predictive value, CTA has become useful for exclusion of CAD in patients with chest pain syndromes. However, the clinical management of a patient with an abnormal CTA is not well defined. Further, several caveats remain regarding the use of coronary CTA. Despite the anatomic data provided by CTA, it does not yield information regarding the functional consequences of the obstruction. Moreover, this technique may miss small vessel disease because of limited resolution and may not be useful in the presence of significant vessel calcium or coronary stents. Most importantly, there is no long-term data regarding the prognostic ability of coronary CTA in the initial evaluation of patients at intermediate risk of coronary events. An abnormal CTA result often leads to additional functional testing or invasive coronary angiography. The major drawback of performing two or more tests in tandem is that it greatly adds to cost that can be prohibitive in lower and middle income countries. Therefore, there is a need to determine if either stress MPI or CTA performed initially, results in meaningful differences in costs without adversely affecting clinical outcomes.
The primary objective of this pilot study is to compare the efficacy (in terms of reduced additional non-invasive or invasive testing) and costs of a strategy of initial stress-rest MPI, to a strategy of initial coronary CTA in the management of asymptomatic or mildly symptomatic patients who are at intermediate risk of coronary events (death or nonfatal MI) by the Framingham criteria.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coronary CTA | Experimental | Other: Coronary CTA, Other: Stress MPI SPECTCoronary CTA using standard protocols |
| Stress MPI SPECT | Active comparator | Other: Coronary CTA, Other: Stress MPI SPECTStress-rest MPI SPECT using standard protocols |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consenting patients above 21 years who are mildly symptomatic (those in class II NYHA), who have an intermediate likelihood of CAD, or asymptomatic patients who are determined to be at intermediate or high risk of coronary events by the Framingham (ATP III) criteria
Key exclusion criteria (8 listed)
- Patients with prior documented CAD (by angiography), MI, coronary stenting or bypass surgery
- Patients in class III or IV NYHA
- Patients with chronic renal impairment to the extent of precluding contrast injection
- Severe medical disease with limited expectancy of life
- Contra-indication or allergy to pharmacologic stress agents or contrast agents
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 |
|---|---|---|
| Coronary CTACoronary CTA using standard protocols | Other | Coronary CTA, Stress MPI SPECT |
| Stress MPI SPECTStress MPI using standard protocols | Other | Coronary CTA, Stress MPI SPECT |
Primary outcome
Proportion of patients who have additional non-invasive testing with another modality, or invasive coronary angiography within 6 months of the first test.
Time frame: 6 months
The primary objective is to compare the efficacy (in terms of reduced additional non-invasive or invasive testing) and costs (at 6 months) of a strategy of initial stress-rest MPI, to a strategy of initial coronary CTA in the management of asymptomatic patients at intermediate or high risk of coronary events by the Framingham criteria, or mildly symptomatic patients who are at intermediate likelihood of having CAD.
Costs of investigation and treatment in both groups
Time frame: 6 months
To compare costs between a strategy of initial stress-rest MPI with a strategy of initial coronary CTA in the management of asymptomatic patients at intermediate or high risk of coronary events by the Framingham criteria, or mildly symptomatic patients who are at intermediate likelihood of having CAD.
1 secondary outcome
Proportion of patients who have planned, elective invasive angiography, elective coronary revascularization, or MACE at 6 month and at 1-year follow up
Time frame: 6 months and 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2015.
- Derived from this study: PubMed 27796852Karthikeyan G, Guzic Salobir B, Jug B, Devasenapathy N, Alexanderson E, Vitola J, Kraft O, Ozkan E, Sharma S, Purohit G, Dolenc Novak M, Meave A, Trevethan S, Cerci R, Zier S, Gotthardtova L, Jonszta T, Altin T, Soydal C, Patel C, Gulati G, Paez D, Dondi M, Kashyap R. Functional compared to anatomical imaging in the initial evaluation of patients with suspected coronary artery disease: An international, multi-center, randomized controlled trial (IAEA-SPECT/CTA study). J Nucl Cardiol. 2017 Apr;24(2):507-517. doi: 10.1007/s12350-016-0664-3. Epub 2016 Oct 28.
Related trials for Coronary Artery Disease
Active, not recruitingPhase 4
Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD
Coronary Artery Disease
RecruitingObservational study
Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors
Testicular Cancer, Survivorship
Recruiting
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
Coronary Arterial Disease (CAD), Plaque
Recruiting
A Prospective, Multicenter, Randomized Controlled Trial to Investigate the Value of Coronary CT Angiography in the Understanding and Management of Coronary Calcium (The Optimal Trial)
Cardiovascular Diseases, Myocardial Ischemia
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease
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.
Ganesan Karthikeyan, MD,DM,MSc principal investigator
All India Institute of Medical Sciences
Salah E Bouyoucef principal investigator
Centre Hospitalier Universitaire de Bab El-Qued
Jorge Cachero principal investigator
Hospital Italiano Garibaldi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Coronary CTA and Stress MPI SPECT in people with Coronary Artery Disease, run by All India Institute of Medical Sciences at 1 site in India.
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 1 inclusion and 8 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: finished, as of the sponsor's last update on 2 Apr 2015. 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 India. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of patients who have additional non-invasive testing with another modality, or invasive coronary angiography within 6 months of the first test. (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT01368770, which also lists 1 linked publication.
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 2 Apr 2015; AzTrials last refreshed its copy on 31 Oct 2026.