Hypertrophic CardiomyopathyPhase 2SCARNCT01230918
Study to Develop a Non-invasive Marker for Monitoring Myocardial Fibrosis
A Phase 2 study testing 99mTc-NC100692 in people with Hypertrophic Cardiomyopathy and Acute Coronary Syndrome, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
Trial summary
The objective is to determine whether 99Technetium-NC100692 uptake in patients with ACS (MI) can serve as a marker for scar formation as detected by contrast-enhanced MRI during the process of myocardial remodelling after the ischemic insult. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertrophic Cardiomyopathy, Acute Coronary Syndrome
- What is being tested?
- 99mTc-NC100692
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- May 2011to 20 Apr 2017
- Phase
- Phase 2
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of HCM as defined as: Interventricular septal thickness greater than 12 mm on a 2D echocardiogram, or septal: posterior wall thickness as measured on parasternal long axis view of >1.3 in the absence of secondary causes of cardiac hypertrophy such as aortic stenosis and systemic hypertension.
- Diagnosis of ACS, either NSTEMI as determined by positive myocardial markers or STEMI patients who have an onset of symptoms 12 hours or less before presentation and an ST-segment elevation of at least 1 mm in two or more contiguous limb leads or of at least 2 mm in two or more contiguous precordial leads during prehospital 12-lead ECGs. Patients will undergo 99mTc-NC100692 imaging within 1 week of acute myocardial infarction.
- No clinically significant chronic or acute illness as determined by history, echocardiogram and/or available reports.
- The subject is greater than or equal to 18 years of age at study entry.
- Before any study procedure is carried out, the subject is able and willing to comply with study procedures and has provided signed and dated informed consent, including permission to access medical records.
- The subject is male, or a female who is either surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom the result of a urine pregnancy test performed before administration of IMP is negative.
Who cannot join
- Concomitant diseases that can lead to myocardial hypertrophy including valvular heart disease and uncontrolled hypertension. If HCM is proven by either the presence of a family history of HCM or through genotyping, patients with controlled hypertension will not be excluded.
- Documented coronary artery disease including a history of previous myocardial infarction or coronary intervention or revascularization.
- Known diabetic cardiomyopathy.
- ACS Population:
- Patients presenting with an acute STEMI secondary to an occlusive thrombus who were revascularized with coronary artery bypass surgery.
- Patients with a known prior history of cardiomyopathy of any cause (ex. ischemic, hypertrophic, infiltrative, idiopathic dilated), preceding the index referral for primary PCI.
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- Hemodynamic instability or cardiogenic shock.
- Normal Control:
- Subjects with pre-existing confounding factors, such as hypertension, diabetes mellitus, hyperlipidemia, CAD, known structural heart disease, left ventricular dysfunction, previous cerebrovascular event, malignancy, connective tissue or inflammatory disease, chronic infection, and hepatic or renal impairment will be excluded.
- Possess abnormal cardiac structure and function after examination with ECHO
- All populations:
- Hypersensitivity to any component of 99mTc-NC100692 injection (e.g. p- aminobenzoate).
- Pregnancy.
- Unwillingness to provide and sign for informed consent.
- Creatinine clearance <30 ml/min.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Technetium-NC100692 SCintigraphy to Detect avB3 Integrin Expression as a mARker of Fibrosis in Hypertrophic Cardiomyopathy and Acute Coronary Syndrome: the SCAR Study
The objective is to determine whether 99Technetium-NC100692 uptake in patients with ACS (MI) can serve as a marker for scar formation as detected by contrast-enhanced MRI during the process of myocardial remodelling after the ischemic insult.
Comparison of ACS and HCM Populations:
Read more
The primary objective is to determine whether TcNC100692 imaging is able to quantify the extent to which myocardial fibrogenesis occurring early post myocardial infarction differs from that in patients with hypertrophic cardiomyopathy.
The primary hypothesis is that since fibrogenesis is known to occur most intensely in the first days to weeks post myocardial infarction, while it is a more protracted, less predictable process in HCM, there will be significantly more TcNC100692 uptake in the early post-ACS population than in the HCM population.
Control Population:
Normal control images will allow for differentiation of uptake in the myocardium.
Read the detailed description
HCM Population:
The primary objective is to determine whether fibrosis detected by MRI and 99mTc-NC100692 uptake in patients with HCM are associated. The secondary objective is to determine whether 99mTc-NC100692 uptake correlates on a segmental basis with fibrosis visualised by late Gd-enhancement MRI. The tertiary objective is to evaluate the relationship between the extent of fibrosis assessed by 99mTc-NC100692 uptake and mean longitudinal strain as determined by speckle tracking echocardiography.
The primary hypothesis is that there is an increased uptake of 99mTc-NC100692 in patients with HCM fibrosis detected by MRI. The secondary hypothesis is that the location and extent of increased 99mTc-NC100692 uptake will correlate with localization and extent measurements of fibrosis by Gd-enhanced magnetic resonance imaging. The tertiary hypothesis is that the extent of fibrosis assessed by the number of segments with and the magnitude of 99mTc NC100692 uptake will correlate with mean longitudinal strain as determined by speckle tracking echocardiography.
ACS Population:
The objective is to determine whether 99Technetium-NC100692 uptake in patients with ACS (MI) can serve as a marker for scar formation as detected by contrast-enhanced MRI during the process of myocardial remodelling after the ischemic insult.
The primary hypothesis is that there is an increased uptake of 99Technetium-NC100692 in patients following an ACS event (MI) and that the location and extent of increased 99Technetium-NC100692 uptake will correlate with the presence and extent of scar as detected by contrast-enhanced magnetic resonance imaging.
Normal Control Population:
Preliminary analysis of images from HCM population showed a diffuse, low grade uptake of 99Technetium-NC100692 in non-hypertrophied myocardial segments. Although not entirely unexpected, comparison with control images will allow for quantification of low grade fibrosis and low grade uptake.
- Being tested
- 99mTc-NC100692
- Keywords
- Hypertrophic Cardiomyopathy, Acute Coronary Syndrome, Myocardial Fibrosis, Fibrogenesis, Intimal Hyperplasia, Sudden Death, avB3 Integrin Expression
- Medical subject headings
- Cardiomyopathy, Hypertrophic, Acute Coronary Syndrome, Death, Sudden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
99mTc-NC100692Radiation
HCM and ACS subjects: 99mTc-NC100692 SPECT scan, CMR and echocardiography images will be obtained and compared.
Normal control: 99mTc-NC100692 SPECT scan, CMR and echocardiography imaging obtained for comparison with HCM and ACS images.
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic Imaging | Experimental | A single dose of 800 to 1100 mBq of 99mTc-NC100692 radiopharmaceutical will be injected. Serial cardiac nuclear imaging will be done over a 3 hour period. Receives: Radiation: 99mTc-NC100692 |
What is being measured
The primary outcome is the main question the study is designed to answer.
TcNC100692 uptake
The primary objective is to determine whether TcNC100692 imaging is able to quantify the extent to which myocardial fibrogenesis occurring early post myocardial infarction differs from that in patients with hypertrophic cardiomyopathy.
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2010 (estimated)
- Study startMay 2011
- Primary completion20 Apr 2017
- Study completion20 Apr 2017
Why it stopped: Costs of study procedures has changed and escalated and became prohibitive.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Ottawa Heart Institute Research CorporationThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Terrence Ruddy, Ottawa Heart Institute Research Corporation
- Investigators
- Terrence Ruddy, MD, Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01230918
- Sponsor's protocol ID
- HI Protocol #2009641-01H
- Acronym
- SCAR
- Status last verified
- Apr 2017
- First submitted
- 28 Oct 2010
- Last updated
- 24 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technetium-NC100692 SCintigraphy to Detect avB3 Integrin Expression as a mARker of Fibrosis in Hypertrophic Cardiomyopathy and Acute Coronary Syndrome: the SCAR Study
- ClinicalTrials.gov ID
- NCT01230918
- Acronym / sponsor ID
- SCAR / HI Protocol #2009641-01H
- Keywords
- Hypertrophic Cardiomyopathy, Acute Coronary Syndrome, Myocardial Fibrosis, Fibrogenesis, Intimal Hyperplasia, Sudden Death, avB3 Integrin Expression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Costs of study procedures has changed and escalated and became prohibitive.
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- 20 Apr 2017 (actual)
- Study completion
- 20 Apr 2017 (actual)
- First posted
- 29 Oct 2010 (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 objective is to determine whether 99Technetium-NC100692 uptake in patients with ACS (MI) can serve as a marker for scar formation as detected by contrast-enhanced MRI during the process of myocardial remodelling after the ischemic insult.
Comparison of ACS and HCM Populations:
The primary objective is to determine whether TcNC100692 imaging is able to quantify the extent to which myocardial fibrogenesis occurring early post myocardial infarction differs from that in patients with hypertrophic cardiomyopathy.
The primary hypothesis is that since fibrogenesis is known to occur most intensely in the first days to weeks post myocardial infarction, while it is a more protracted, less predictable process in HCM, there will be significantly more TcNC100692 uptake in the early post-ACS population than in the HCM population.
Control Population:
Normal control images will allow for differentiation of uptake in the myocardium.
Detailed description
HCM Population:
The primary objective is to determine whether fibrosis detected by MRI and 99mTc-NC100692 uptake in patients with HCM are associated. The secondary objective is to determine whether 99mTc-NC100692 uptake correlates on a segmental basis with fibrosis visualised by late Gd-enhancement MRI. The tertiary objective is to evaluate the relationship between the extent of fibrosis assessed by 99mTc-NC100692 uptake and mean longitudinal strain as determined by speckle tracking echocardiography.
The primary hypothesis is that there is an increased uptake of 99mTc-NC100692 in patients with HCM fibrosis detected by MRI. The secondary hypothesis is that the location and extent of increased 99mTc-NC100692 uptake will correlate with localization and extent measurements of fibrosis by Gd-enhanced magnetic resonance imaging. The tertiary hypothesis is that the extent of fibrosis assessed by the number of segments with and the magnitude of 99mTc NC100692 uptake will correlate with mean longitudinal strain as determined by speckle tracking echocardiography.
ACS Population:
The objective is to determine whether 99Technetium-NC100692 uptake in patients with ACS (MI) can serve as a marker for scar formation as detected by contrast-enhanced MRI during the process of myocardial remodelling after the ischemic insult.
The primary hypothesis is that there is an increased uptake of 99Technetium-NC100692 in patients following an ACS event (MI) and that the location and extent of increased 99Technetium-NC100692 uptake will correlate with the presence and extent of scar as detected by contrast-enhanced magnetic resonance imaging.
Normal Control Population:
Preliminary analysis of images from HCM population showed a diffuse, low grade uptake of 99Technetium-NC100692 in non-hypertrophied myocardial segments. Although not entirely unexpected, comparison with control images will allow for quantification of low grade fibrosis and low grade uptake.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic Imaging | Experimental | Radiation: 99mTc-NC100692A single dose of 800 to 1100 mBq of 99mTc-NC100692 radiopharmaceutical will be injected. Serial cardiac nuclear imaging will be done over a 3 hour period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of HCM as defined as: Interventricular septal thickness greater than 12 mm on a 2D echocardiogram, or septal: posterior wall thickness as measured on parasternal long axis view of >1.3 in the absence of secondary causes of cardiac hypertrophy such as aortic stenosis and systemic hypertension.
- Diagnosis of ACS, either NSTEMI as determined by positive myocardial markers or STEMI patients who have an onset of symptoms 12 hours or less before presentation and an ST-segment elevation of at least 1 mm in two or more contiguous limb leads or of at least 2 mm in two or more contiguous precordial leads during prehospital 12-lead ECGs. Patients will undergo 99mTc-NC100692 imaging within 1 week of acute myocardial infarction.
- No clinically significant chronic or acute illness as determined by history, echocardiogram and/or available reports.
- The subject is greater than or equal to 18 years of age at study entry.
- Before any study procedure is carried out, the subject is able and willing to comply with study procedures and has provided signed and dated informed consent, including permission to access medical records.
Key exclusion criteria (15 listed)
- Concomitant diseases that can lead to myocardial hypertrophy including valvular heart disease and uncontrolled hypertension. If HCM is proven by either the presence of a family history of HCM or through genotyping, patients with controlled hypertension will not be excluded.
- Documented coronary artery disease including a history of previous myocardial infarction or coronary intervention or revascularization.
- Known diabetic cardiomyopathy.
- Patients presenting with an acute STEMI secondary to an occlusive thrombus who were revascularized with coronary artery bypass surgery.
- Patients with a known prior history of cardiomyopathy of any cause (ex. ischemic, hypertrophic, infiltrative, idiopathic dilated), preceding the index referral for primary PCI.
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 |
|---|---|---|
| 99mTc-NC100692HCM and ACS subjects: 99mTc-NC100692 SPECT scan, CMR and echocardiography images will be obtained and compared. Normal control: 99mTc-NC100692 SPECT scan, CMR and echocardiography imaging obtained for comparison with HCM and ACS images. | Radiation | Diagnostic Imaging |
Primary outcome
TcNC100692 uptake
Time frame: 3 hours
The primary objective is to determine whether TcNC100692 imaging is able to quantify the extent to which myocardial fibrogenesis occurring early post myocardial infarction differs from that in patients with hypertrophic cardiomyopathy.
Results and safety
The study was stopped early (reason given: Costs of study procedures has changed and escalated and became prohibitive.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2017.
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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.
Terrence Ruddy, MD principal investigator
Ottawa Heart Institute Research Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 99mTc-NC100692 in people with Hypertrophic Cardiomyopathy and Acute Coronary Syndrome, run by Ottawa Heart Institute Research Corporation 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 6 inclusion and 15 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: stopped early, as of the sponsor's last update on 24 Apr 2017. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Costs of study procedures has changed and escalated and became prohibitive.). Results are not available in the source record.
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?
TcNC100692 uptake (time frame: 3 hours). 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 24 Apr 2017.