ST Elevation (STEMI) Myocardial Infarction of Anterior WallPhase 1BELIEVE IIINCT02071602
CD-NP (Cenderitide) Therapy for the Preservation of Left Ventricular Function
A Phase 1 study testing CD-NP in people with ST Elevation (STEMI) Myocardial Infarction of Anterior Wall, run by Mayo Clinic at 1 site in United States.
Trial summary
The primary endpoint is to assess the safety and tolerability of Cenderitide (CD-NP) with the incidence of symptomatic hypotension being one of the key safety variables. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST Elevation (STEMI) Myocardial Infarction of Anterior Wall
- What is being tested?
- CD-NP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Nov 2018
- Phase
- Phase 1
- 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
- Significant chest discomfort and /or shortness of breath
- ST segment elevation (1.5 mV total) in two or more adjacent anterior precordial leads
- Successful reperfusion therapy (>TIMI grade 2 flow) either with thrombolytics or any mechanical forms of revascularization, including stent, PTCA, thrombectomy, etc. within 24 hours of onset of symptoms as documented by coronary angiography
- No previously known history of AMI (prior to current cardiac event) or no previous ECG (prior to current cardiac event) suggesting an old AMI (Q wave on presenting ECG is not an exclusion)..
- Exclusion Criteria:(Assessed at the time of enrollment unless otherwise stated)
- Cardiogenic shock, acute heart failure or hypotension (Systolic BP < 90 mmHg)
Show all 25Show fewer
- Previous known decreased EF < 40%
- Atrial Fibrillation
- Persistent signs and symptoms of Post MI ischemia
- Requirement of pressors for maintenance of blood pressure.
- Intra-aortic blood pump use
- Significant (moderate-severe) valvular stenosis, hypertrophic, restrictive or obstructive cardiomyopathy, constrictive pericarditis, primary pulmonary hypertension.
- Severe congenital heart diseases
- Sustained ventricular tachycardia or ventricular fibrillation
- Second or third degree heart block without a permanent cardiac pacemaker
- Stroke within 3 months or other evidence of significantly compromised CNS perfusion
- Total bilirubin of > 2.5 mg/dL or other liver enzymes >2.5 times the upper limit of normal if available clinically and measured within the last 7 days
- Patients with calculated GFR <30 ml by MDRD equation or those with acute kidney injury as defined by an increase of plasma creatinine of 0.5 mg/dL from a plasma creatinine measured within the last 7 days
- Serum sodium of < 125 mEq/dL or > 160 mEq/dL if available clinically and measured within the last 7 days
- Serum potassium of < 3.0 mEq/dL or > 5.8 mEq/dL if available clinically and measured within the last 7 days
- Hemoglobin < 8.5 gm/dl if available clinically and measured within the last 7 days
- Other acute or chronic medical conditions or laboratory abnormality which may increase the risks associated with study participation or may interfere with interpretation of the data
- Received an investigational drug within 1 month prior to dosing
- Female subject who is pregnant or breastfeeding
- In the opinion of the investigator, is unlikely to comply with the study protocol or is unsuitable for any reasons
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: CD-NP (Cenderitide) Therapy for the Preservation of Left Ventricular Function Post Anterior Myocardial Infarction - Pilot Study
The primary endpoint is to assess the safety and tolerability of Cenderitide (CD-NP) with the incidence of symptomatic hypotension being one of the key safety variables.
Read the detailed description
This is a "proof of concept", randomized, double-blind, placebo controlled study. The study population will include 60 patients admitted with a first time ST elevation anterior STEMI as diagnosed by the following criteria: a) Significant chest discomfort and /or shortness of breath; b) ST segment elevation (1.5 mV total) in two or more adjacent anterior precordial leads; c) Successful reperfusion therapy (>TIMI grade 2 flow) either with thrombolytics or PTCA within 24 hours of onset of symptoms as documented by coronary angiography; and d) No previous history of an anterior AMI or previous ECG suggesting an old anterior AMI.
Patients will be randomized to one of two doses of CD-NP (5 ng/kg/min and 10 ng/kg/min) or placebo continuous infusion for up to 72 hours in a 1:1:1 manner. All patients will receive other standard medical therapies as determined appropriate by the physician and in accordance to the ACC/AHA guidelines
- Being tested
- CD-NP
- Keywords
- Heart attack, Myocardial Infarction, STEMI
- Medical subject headings
- ST Elevation Myocardial Infarction, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD-NPDrug
Also called Cenderitide
Randomized 1:1:1
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo infused for up to 72 hours IV Receives: Drug: CD-NP |
| CD-NP 5 ng/kg/min | Active comparator | CD-NP 5 ng/kg/min infused for up to 72 hours IV Receives: Drug: CD-NP |
| CD-NP 10 ng/kg/min | Placebo comparator | CD-NP 10 ng/kg/min infused for up to 72 hours IV Receives: Drug: CD-NP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with symptomatic hypotension
Measured: baseline to 30 days
Secondary outcomes (2)
Comparison of LV function improvement between placebo vs. CD-NP groups
Measured: baseline to 30 days
Exploratory analyses of Major Adverse Cardiovascular Events (MACE)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2014 (estimated)
- Study startOct 2013
- Primary completionMay 2018
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST Elevation (STEMI) Myocardial Infarction of Anterior WallStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Horng Chen, Mayo Clinic
- Investigators
- Horng Chen, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02071602
- Sponsor's protocol ID
- 12-006317
- Acronym
- BELIEVE III
- Status last verified
- Mar 2021
- First submitted
- 15 Nov 2013
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CD-NP (Cenderitide) Therapy for the Preservation of Left Ventricular Function Post Anterior Myocardial Infarction - Pilot Study
- ClinicalTrials.gov ID
- NCT02071602
- Acronym / sponsor ID
- BELIEVE III / 12-006317
- Keywords
- Heart attack, Myocardial Infarction, STEMI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- May 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 26 Feb 2014 (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 primary endpoint is to assess the safety and tolerability of Cenderitide (CD-NP) with the incidence of symptomatic hypotension being one of the key safety variables.
Detailed description
This is a "proof of concept", randomized, double-blind, placebo controlled study. The study population will include 60 patients admitted with a first time ST elevation anterior STEMI as diagnosed by the following criteria: a) Significant chest discomfort and /or shortness of breath; b) ST segment elevation (1.5 mV total) in two or more adjacent anterior precordial leads; c) Successful reperfusion therapy (>TIMI grade 2 flow) either with thrombolytics or PTCA within 24 hours of onset of symptoms as documented by coronary angiography; and d) No previous history of an anterior AMI or previous ECG suggesting an old anterior AMI.
Patients will be randomized to one of two doses of CD-NP (5 ng/kg/min and 10 ng/kg/min) or placebo continuous infusion for up to 72 hours in a 1:1:1 manner. All patients will receive other standard medical therapies as determined appropriate by the physician and in accordance to the ACC/AHA guidelines
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: CD-NPPlacebo infused for up to 72 hours IV |
| CD-NP 5 ng/kg/min | Active comparator | Drug: CD-NPCD-NP 5 ng/kg/min infused for up to 72 hours IV |
| CD-NP 10 ng/kg/min | Placebo comparator | Drug: CD-NPCD-NP 10 ng/kg/min infused for up to 72 hours IV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Significant chest discomfort and /or shortness of breath
- ST segment elevation (1.5 mV total) in two or more adjacent anterior precordial leads
- Successful reperfusion therapy (>TIMI grade 2 flow) either with thrombolytics or any mechanical forms of revascularization, including stent, PTCA, thrombectomy, etc. within 24 hours of onset of symptoms as documented by coronary angiography
- No previously known history of AMI (prior to current cardiac event) or no previous ECG (prior to current cardiac event) suggesting an old AMI (Q wave on presenting ECG is not an exclusion)..
- Exclusion Criteria:(Assessed at the time of enrollment unless otherwise stated)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| CD-NPAlso: CenderitideRandomized 1:1:1 | Drug | CD-NP 10 ng/kg/min, CD-NP 5 ng/kg/min, Placebo |
Primary outcome
Number of subjects with symptomatic hypotension
Time frame: baseline to 30 days
2 secondary outcomes
Comparison of LV function improvement between placebo vs. CD-NP groups
Time frame: baseline to 30 days
Exploratory analyses of Major Adverse Cardiovascular Events (MACE)
Time frame: 30 days
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 10 Mar 2021.
- Related InfoLink provided by the sponsor.
Related trials for ST Elevation (STEMI) Myocardial Infarction of Anterior Wall
RecruitingPhase 2
A Research Study to Evaluate the Efficacy and Safety of SGC001 in Patients With Anterior Wall ST-Segment Elevation Myocardial Infarction
Acute Anterior ST-Segment Elevation Myocardial Infarction
Not yet recruitingPhase 2
Recombinant Human Thymosin Beta 4 for Injection(NL005) for Acute Myocardial Infarction
Acute Myocardial Infarction (AMI), Acute Myocardial Infarction of Anterior Wall
Active, not recruiting
Primary Unloading and Delayed Reperfusion in ST-Elevation Myocardial Infarction: The STEMI-DTU Trial
ST Elevation (STEMI) Myocardial Infarction of Anterior Wall
Not yet recruiting
Impact, Cost, and Sustainability of a Customized, Low-Cost Intervention to Reduce Cardiovascular Disease Burden in India: A Cluster Randomized Trial
ST Elevation (STEMI) Myocardial Infarction of Anterior Wall, Cardiovascular Diseases
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.
Horng Chen, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CD-NP in people with ST Elevation (STEMI) Myocardial Infarction of Anterior Wall, run by Mayo Clinic at 1 site in United States.
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 25 inclusion and 0 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 10 Mar 2021. 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 United States. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Number of subjects with symptomatic hypotension (time frame: baseline to 30 days). 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 10 Mar 2021.