Myocardial InfarctionPhase 2NCT00881075
Safety and Efficacy of SeeMore (TM) in Heart Patients
A Phase 2 study testing SeeMore(TM) in people with Myocardial Infarction, run by Eagle Vision Pharmaceutical Corp..
Trial summary
This study will examine the safety and effectiveness of a manganese-based agent called SeeMore (EVP 1001-1 Injection) for enhancing magnetic resonance imaging (MRI) in patients who have previously had a heart attack. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- SeeMore(TM)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Jun 2008to Mar 2012
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- be at least 18 years of age.
- if female, be nonpregnant as evidenced by a serum pregnancy test and using a medically-approved method of birth control, or post-menopausal or surgically sterile
- provide written informed consent after having received oral and written information about the study
- be in stable health based on medical history, examination and tests
- have potassium, calcium and hematocrit values within normal limits
- have a prior known myocardial infarction
Who cannot join
- have a positive pregnancy test (females)
- received an investigational drug or device within 30 days prior to administration of SeeMore™
- have known hypersensitivity to ondansetron or other selective serotonin 5HT3 receptor blockers
- have a history of drug abuse or alcoholism
- have had a myocardial infarct, unstable angina, stroke of transient ischemic attack (TIA) within the past six months
- are taking a digitalis preparation or calcium channel blocker
Show all 16Show fewer
- have arrhythmias requiring medication
- have a prolonged PR interval, history of an atrioventricular conduction disorder or sick sinus syndrome
- have a prolonged QTc interval, ventricular arrhythmia or history of torsades
- have NYHA Grade III or IV heart failure
- have abnormal liver function tests or a history of liver disease
- have uncontrolled hypertension
- have potassium, calcium or hematocrit values outside normal limits
- have altered a prescription medication within 14 days or an over-the-counter medication within 7 days
- are noncompliant or otherwise unlikely to perform as required by the protocol
- if a new cardiac arrhythmia develops prior to the scheduled time for SeeMore™ administration, SeeMore™ will be withheld.
About this study
Official title: An Open-label, Baseline-Controlled Study of the Safety and Efficacy of SeeMore (TM) (EVP 1001-1 Injection) in Heart Patients
This study will examine the safety and effectiveness of a manganese-based agent called SeeMore (EVP 1001-1 Injection) for enhancing magnetic resonance imaging (MRI) in patients who have previously had a heart attack. It will determine whether SeeMore makes it easier to find damaged areas of the heart and will evaluate how well patients feel and how their bodies react after receiving the study medication.
Adult patients who have previously had a heart attack and are in stable health may be eligible for this study. Candidates are screened with a medical history, a brief physical examination and blood and urine tests.
Read more
Participants undergo the following procedures:
- Collection of blood and urine samples 24 hours before receiving SeeMore and 24 hours after. A blood sample is also taken 3 and 10 days after receiving the drug.
- MRI scans one hour before receiving SeeMore and 10 minutes after receiving the drug. MRI uses a magnetic field and radio waves to produce images of body tissues and organs. After the first (baseline) MRI is done, SeeMore is given intravenously (through a vein) and the subject's vital signs and electrocardiogram (EKG) are monitored for 10 minutes. Then the second MRI is done to determine whether the study medication makes it easier to see areas of the heart that were affected by the heart attack.
- Check of vital signs, EKG and physical examination after the second MRI.
Read the detailed description
This is a Phase II open-label, baseline-controlled study. Approximately 10 adult male or nonpregnant female patients known to have had a myocardial infarct (nonacute) are intended to be enrolled at the current dose.
Prior to entry into this study, all subjects will undergo a standard physical examination including medical history, details regarding the prior myocardial infarct(s), prescription and over-the-counter drug questionnaire, vital signs, ECG, evaluation of the major organ systems, hematology, serum chemistries, and urinalysis. In addition, female subjects will undergo a serum pregnancy test. All subjects will sign an Informed Consent prior to entry into the study.
EVP 1001-1 will be administered intravenously over approximately one minute. Safety will be assessed by monitoring vital signs, ECG, and blood test after giving EVP 1001-1. MRI will be performed before and after EVP-1001-1 to measure enhancement relative to areas of myocardial infarction.
- Conditions
- Myocardial Infarction
- Being tested
- SeeMore(TM)
- Keywords
- Magnetic resonance imaging, Heart diseases, myocardial infarction, contrast agents, manganese
- Medical subject headings
- Myocardial Infarction, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeeMore(TM)Drug
Also called EVP 1001-1
single dose intravenous injectable
| Study group | Role | What they receive |
|---|---|---|
| SeeMore(TM) | Experimental | intravenous imaging agent for enhanced magnetic resonance imaging. Receives: Drug: SeeMore(TM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Examine the safety and tolerance of SeeMore following intravenous injection in patients known to have had a myocardial infarct
Measured: within 24 hours
Secondary outcomes (1)
To assess the efficacy (enhancement features) of SeeMore for identifying myocardial infarction
Measured: within 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2009 (estimated)
- Study startJun 2008
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eagle Vision Pharmaceutical Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00881075
- Sponsor's protocol ID
- 1001-1:201
- Status last verified
- Feb 2016
- First submitted
- 14 Apr 2009
- Last updated
- 4 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Mendonca-Dias MH, Gaggelli E, Lauterbur PC. Paramagnetic contrast agents in nuclear magnetic resonance medical imaging. Semin Nucl Med. 1983 Oct;13(4):364-76. doi: 10.1016/s0001-2998(83)80048-8.
PubMed 6359418Storey P, Danias PG, Post M, Li W, Seoane PR, Harnish PP, Edelman RR, Prasad PV. Preliminary evaluation of EVP 1001-1: a new cardiac-specific magnetic resonance contrast agent with kinetics suitable for steady-state imaging of the ischemic heart. Invest Radiol. 2003 Oct;38(10):642-52. doi: 10.1097/01.rli.0000077057.88108.3f.
PubMed 14501492Storey P, Chen Q, Li W, Seoane PR, Harnish PP, Fogelson L, Harris KR, Prasad PV. Magnetic resonance imaging of myocardial infarction using a manganese-based contrast agent (EVP 1001-1): preliminary results in a dog model. J Magn Reson Imaging. 2006 Feb;23(2):228-34. doi: 10.1002/jmri.20500.
PubMed 16416440
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Baseline-Controlled Study of the Safety and Efficacy of SeeMore (TM) (EVP 1001-1 Injection) in Heart Patients
- ClinicalTrials.gov ID
- NCT00881075
- Acronym / sponsor ID
- 1001-1:201
- Conditions
- Myocardial Infarction
- Keywords
- Magnetic resonance imaging, Heart diseases, myocardial infarction, contrast agents, manganese
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Eagle Vision Pharmaceutical Corp.Industry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 15 Apr 2009 (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.
This study will examine the safety and effectiveness of a manganese-based agent called SeeMore (EVP 1001-1 Injection) for enhancing magnetic resonance imaging (MRI) in patients who have previously had a heart attack. It will determine whether SeeMore makes it easier to find damaged areas of the heart and will evaluate how well patients feel and how their bodies react after receiving the study medication.
Adult patients who have previously had a heart attack and are in stable health may be eligible for this study. Candidates are screened with a medical history, a brief physical examination and blood and urine tests.
Participants undergo the following procedures:
- Collection of blood and urine samples 24 hours before receiving SeeMore and 24 hours after. A blood sample is also taken 3 and 10 days after receiving the drug.
- MRI scans one hour before receiving SeeMore and 10 minutes after receiving the drug. MRI uses a magnetic field and radio waves to produce images of body tissues and organs. After the first (baseline) MRI is done, SeeMore is given intravenously (through a vein) and the subject's vital signs and electrocardiogram (EKG) are monitored for 10 minutes. Then the second MRI is done to determine whether the study medication makes it easier to see areas of the heart that were affected by the heart attack.
- Check of vital signs, EKG and physical examination after the second MRI.
Detailed description
This is a Phase II open-label, baseline-controlled study. Approximately 10 adult male or nonpregnant female patients known to have had a myocardial infarct (nonacute) are intended to be enrolled at the current dose.
Prior to entry into this study, all subjects will undergo a standard physical examination including medical history, details regarding the prior myocardial infarct(s), prescription and over-the-counter drug questionnaire, vital signs, ECG, evaluation of the major organ systems, hematology, serum chemistries, and urinalysis. In addition, female subjects will undergo a serum pregnancy test. All subjects will sign an Informed Consent prior to entry into the study.
EVP 1001-1 will be administered intravenously over approximately one minute. Safety will be assessed by monitoring vital signs, ECG, and blood test after giving EVP 1001-1. MRI will be performed before and after EVP-1001-1 to measure enhancement relative to areas of myocardial infarction.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SeeMore(TM) | Experimental | Drug: SeeMore(TM)intravenous imaging agent for enhanced magnetic resonance imaging. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- be at least 18 years of age.
- if female, be nonpregnant as evidenced by a serum pregnancy test and using a medically-approved method of birth control, or post-menopausal or surgically sterile
- provide written informed consent after having received oral and written information about the study
- be in stable health based on medical history, examination and tests
- have potassium, calcium and hematocrit values within normal limits
Key exclusion criteria (16 listed)
- have a positive pregnancy test (females)
- received an investigational drug or device within 30 days prior to administration of SeeMore™
- have known hypersensitivity to ondansetron or other selective serotonin 5HT3 receptor blockers
- have a history of drug abuse or alcoholism
- have had a myocardial infarct, unstable angina, stroke of transient ischemic attack (TIA) within the past six months
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 |
|---|---|---|
| SeeMore(TM)Also: EVP 1001-1single dose intravenous injectable | Drug | SeeMore(TM) |
Primary outcome
Examine the safety and tolerance of SeeMore following intravenous injection in patients known to have had a myocardial infarct
Time frame: within 24 hours
1 secondary outcome
To assess the efficacy (enhancement features) of SeeMore for identifying myocardial infarction
Time frame: within 1 hour
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 4 Feb 2016.
- Background: PubMed 6359418Mendonca-Dias MH, Gaggelli E, Lauterbur PC. Paramagnetic contrast agents in nuclear magnetic resonance medical imaging. Semin Nucl Med. 1983 Oct;13(4):364-76. doi: 10.1016/s0001-2998(83)80048-8.
- Background: PubMed 14501492Storey P, Danias PG, Post M, Li W, Seoane PR, Harnish PP, Edelman RR, Prasad PV. Preliminary evaluation of EVP 1001-1: a new cardiac-specific magnetic resonance contrast agent with kinetics suitable for steady-state imaging of the ischemic heart. Invest Radiol. 2003 Oct;38(10):642-52. doi: 10.1097/01.rli.0000077057.88108.3f.
- Background: PubMed 16416440Storey P, Chen Q, Li W, Seoane PR, Harnish PP, Fogelson L, Harris KR, Prasad PV. Magnetic resonance imaging of myocardial infarction using a manganese-based contrast agent (EVP 1001-1): preliminary results in a dog model. J Magn Reson Imaging. 2006 Feb;23(2):228-34. doi: 10.1002/jmri.20500.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SeeMore(TM) in people with Myocardial Infarction, run by Eagle Vision Pharmaceutical Corp..
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 16 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 4 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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 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?
Examine the safety and tolerance of SeeMore following intravenous injection in patients known to have had a myocardial infarct (time frame: within 24 hours). 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 NCT00881075, which also lists 3 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 4 Feb 2016.