Myocardial IschemiaMITNECB5NCT01972360
Non-isotope Based Imaging Modalities vs Technetium-99m Single-Photon Emission Computed Tomography(99mTcSPECT)
An observational study of Myocardial Ischemia, run by Montreal Heart Institute at 1 site in Canada.
Trial summary
SPECT is currently the dominant clinical test for diagnostic and prognostic purposes as well as therapeutic decision-making. Given the shortage of nuclear reactor-produced Tc, advancing the use of non-isotope based imaging modalities has the potential to change the standard of care for patients with CAD as each one of… Read more about this study
- Who is it for?
- Ages 18 to 87 years
- Conditions the study is for
- Myocardial Ischemia
- How many people
- 467 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2012to 18 Apr 2019
- 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 to 87 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Approximately 450 patients across Canada. Patients will be identified after a clinically indicated SPECT for evaluation of myocardial ischemia.The investigator will assign the patient in one of the three groups based on his medical assessment and availability of equipment at the centre.
Who may be able to join
- clinically indicated request for SPECT
- ability to undergo at least one of three non-nuclear imaging tests; CMR, CT or Stress Echocardiography
- History of recent symptoms suggestive of myocardial ischemia
- High risk for ischemic cardiovascular events
Who cannot join
- severely reduced systolic function (LV ejection fraction less than 35%)
- Recent (less than 3 days) acute coronary syndrome including acute myocardial infarction
- contraindications to dipyridamole SPECT including : i)severe reactive airway disease; ii) less than 3 days post Myocardial Infarction - Acute Coronary Syndrome (MI-ACS); iii) high-grade Atrioventricular block (AV block); iv)allergy to dipyridamole or theophylline; v) caffeine within 12 hours; vi) theophylline use within 48 hours; vii) severe claustrophobia; or viii) women who may be pregnant
- kidney dysfunction (i.e estimated Glomerular Filtration Rate (eGFR) less than 45)
- use of investigational drug or device within 30 days of screening visit
- Coronary Artery Bypass Graft(s) surgery (CABG)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-isotope Based Imaging Modalities vs 99mTcSPECT to Detect Myocardial Ischemia in Patients at High Risk for Ischemic Cardiovascular Events
SPECT is currently the dominant clinical test for diagnostic and prognostic purposes as well as therapeutic decision-making. Given the shortage of nuclear reactor-produced Tc, advancing the use of non-isotope based imaging modalities has the potential to change the standard of care for patients with CAD as each one of these technics (CMR, CT, Stress echocardiography) has its own distinct potential advantages over SPECT.
Read the detailed description
Obtain a better understanding of the clinical utility of advanced non-isotope-based imaging modalities to detect relevant CAD as potential alternatives to SPECT. Approximately 450 subjects will be enrolled in total. Three groups of about 150 patients per group. Each group will undergo imaging with 2 modalities; Group 1: 99mTcSPECT plus CMR, Group 2: 99mTcSPECT plus CT, Group 3:99mTcSPECT plus stress echocardiography. All 450 patients will undergo standard invasive coronary angiography following completion of non-invasive imaging, except for patients in whom both nuclear and non-nuclear imaging modalities reveal a normal result confirming the absence of significant coronary artery disease (i.e invasive angiography would not be clinically indicated and FFR would be considered to be above 0.8). Thrombolysis in Myocardial Infraction (TIMI) flow will be measured in all patients undergoing angiography, and fractional flow reserve (FFR) will be measured in all patients except those with TIMI flow =0, 1 and 2. All imaging procedures must be completed within 6 weeks. All patients will have a follow-up visit at 6 months after enrollment. During the 6 month follow-up visit major adverse cardiovascular events will be collected and adjudicated by a clinical endpoint committee (CEC).
- Conditions
- Myocardial Ischemia
- Keywords
- SPECT, CMR, High risk for ischemic cardiovascular events
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Diagnosis | Group 3: 99mTCSPECT plus stress echocardiography | |
| group 1 : diagnosis | Group 1: 99mTcSPECT plus CMR | |
| Group 2: diagnosis | Group 2: 99mTcSPECT plus CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall accuracy of "significant coronary artery disease (CAD)" according to non-invasive imaging modality
The overall accuracy is calculated as the probability that a subject is correctly classified (presence of significant CAD or not) by non-invasive imaging modality. The standard of truth is presence of significant CAD or not according to the invasive fractional flow reserve (FFR)
Measured: baseline
Sensitivity of "significant CAD" according to non-invasive imaging modality
The sensitivity is calculated as the probability that a subject with presence of significant CAD according to FFR is correctly identified as such by non-invasive imaging modality
Measured: baseline
Specificity of "significant CAD" according to non-invasive imaging modality
The specificity is calculated as the probability that a subject with absence of significant CAD according to FFR is correctly identified as such by non-invasive imaging modality
Measured: baseline
Positive predictive value of "significant CAD" according to non-invasive imaging modality
The positive predictive value is calculated as the probability that a subject with presence of significant CAD according to non-invasive imaging modality truly have significant CAD according to FFR
Measured: baseline
Negative predictive value of "significant CAD" according to non-invasive imaging modality
The negative predictive value is calculated as the probability that a subject with absence of significant CAD according to non-invasive imaging modality truly does not have significant CAD according to FFR
Measured: Baseline
Secondary outcomes (2)
Overall accuracy of "high-risk CAD" according to non-invasive imaging modality flow and FFR
Measured: baseline
Sensitivity of "high-risk CAD" according to non-invasive imaging modality flow and FFR
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2013 (estimated)
- Study startOct 2012
- Primary completionMay 2018
- Study completion18 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial IschemiaStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 467 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montreal Heart Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Jean-Claude Tardif, M.D, Principal investigator, Montreal Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01972360
- Sponsor's protocol ID
- MITNEC B5
- Acronym
- MITNECB5
- Status last verified
- Feb 2020
- First submitted
- 18 Jul 2013
- Last updated
- 21 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-isotope Based Imaging Modalities vs 99mTcSPECT to Detect Myocardial Ischemia in Patients at High Risk for Ischemic Cardiovascular Events
- ClinicalTrials.gov ID
- NCT01972360
- Acronym / sponsor ID
- MITNECB5 / MITNEC B5
- Conditions
- Myocardial Ischemia
- Keywords
- SPECT, CMR, High risk for ischemic cardiovascular events
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 467 participants (actual)
- Lead sponsor
- Montreal Heart InstituteUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Oct 2012
- Primary completion
- May 2018 (actual)
- Study completion
- 18 Apr 2019 (actual)
- First posted
- 30 Oct 2013 (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.
SPECT is currently the dominant clinical test for diagnostic and prognostic purposes as well as therapeutic decision-making. Given the shortage of nuclear reactor-produced Tc, advancing the use of non-isotope based imaging modalities has the potential to change the standard of care for patients with CAD as each one of these technics (CMR, CT, Stress echocardiography) has its own distinct potential advantages over SPECT.
Detailed description
Obtain a better understanding of the clinical utility of advanced non-isotope-based imaging modalities to detect relevant CAD as potential alternatives to SPECT. Approximately 450 subjects will be enrolled in total. Three groups of about 150 patients per group. Each group will undergo imaging with 2 modalities; Group 1: 99mTcSPECT plus CMR, Group 2: 99mTcSPECT plus CT, Group 3:99mTcSPECT plus stress echocardiography. All 450 patients will undergo standard invasive coronary angiography following completion of non-invasive imaging, except for patients in whom both nuclear and non-nuclear imaging modalities reveal a normal result confirming the absence of significant coronary artery disease (i.e invasive angiography would not be clinically indicated and FFR would be considered to be above 0.8). Thrombolysis in Myocardial Infraction (TIMI) flow will be measured in all patients undergoing angiography, and fractional flow reserve (FFR) will be measured in all patients except those with TIMI flow =0, 1 and 2. All imaging procedures must be completed within 6 weeks. All patients will have a follow-up visit at 6 months after enrollment. During the 6 month follow-up visit major adverse cardiovascular events will be collected and adjudicated by a clinical endpoint committee (CEC).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diagnosis | – | –Group 3: 99mTCSPECT plus stress echocardiography |
| group 1 : diagnosis | – | –Group 1: 99mTcSPECT plus CMR |
| Group 2: diagnosis | – | –Group 2: 99mTcSPECT plus CT |
Who may qualify
- Ages
- 18 to 87 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 450 patients across Canada. Patients will be identified after a clinically indicated SPECT for evaluation of myocardial ischemia.The investigator will assign the patient in one of the three groups based on his medical assessment and availability of equipment at the centre.
Key inclusion criteria (4 listed)
- clinically indicated request for SPECT
- ability to undergo at least one of three non-nuclear imaging tests; CMR, CT or Stress Echocardiography
- History of recent symptoms suggestive of myocardial ischemia
- High risk for ischemic cardiovascular events
Key exclusion criteria (6 listed)
- severely reduced systolic function (LV ejection fraction less than 35%)
- Recent (less than 3 days) acute coronary syndrome including acute myocardial infarction
- contraindications to dipyridamole SPECT including : i)severe reactive airway disease; ii) less than 3 days post Myocardial Infarction - Acute Coronary Syndrome (MI-ACS); iii) high-grade Atrioventricular block (AV block); iv)allergy to dipyridamole or theophylline; v) caffeine within 12 hours; vi) theophylline use within 48 hours; vii) severe claustrophobia; or viii) women who may be pregnant
- kidney dysfunction (i.e estimated Glomerular Filtration Rate (eGFR) less than 45)
- use of investigational drug or device within 30 days of screening visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall accuracy of "significant coronary artery disease (CAD)" according to non-invasive imaging modality
Time frame: baseline
The overall accuracy is calculated as the probability that a subject is correctly classified (presence of significant CAD or not) by non-invasive imaging modality. The standard of truth is presence of significant CAD or not according to the invasive fractional flow reserve (FFR)
Sensitivity of "significant CAD" according to non-invasive imaging modality
Time frame: baseline
The sensitivity is calculated as the probability that a subject with presence of significant CAD according to FFR is correctly identified as such by non-invasive imaging modality
Specificity of "significant CAD" according to non-invasive imaging modality
Time frame: baseline
The specificity is calculated as the probability that a subject with absence of significant CAD according to FFR is correctly identified as such by non-invasive imaging modality
Positive predictive value of "significant CAD" according to non-invasive imaging modality
Time frame: baseline
The positive predictive value is calculated as the probability that a subject with presence of significant CAD according to non-invasive imaging modality truly have significant CAD according to FFR
Negative predictive value of "significant CAD" according to non-invasive imaging modality
Time frame: Baseline
The negative predictive value is calculated as the probability that a subject with absence of significant CAD according to non-invasive imaging modality truly does not have significant CAD according to FFR
2 secondary outcomes
Overall accuracy of "high-risk CAD" according to non-invasive imaging modality flow and FFR
Time frame: baseline
Sensitivity of "high-risk CAD" according to non-invasive imaging modality flow and FFR
Time frame: Baseline
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 21 Feb 2020.
- 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.
Jean-Claude Tardif, M.D principal investigator
Montreal Heart Institute
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 Myocardial Ischemia, run by Montreal Heart Institute at 1 site in Canada.
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 4 inclusion and 6 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 21 Feb 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 Canada. 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?
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?
Overall accuracy of "significant coronary artery disease (CAD)" according to non-invasive imaging modality (time frame: baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Feb 2020.