Acute Myocardial InfarctionTRISNCT02164058
TandemHeart to Reduce Infarct Size (TRIS Trial)
A study testing TandemHeart System and Percutaneous coronary intervention in people with Acute Myocardial Infarction, run by CardiacAssist, Inc..
Trial summary
The purpose of this study is to determine if a device known as the TandemHeart® System (TandemHeart) can help limit heart damage and reduce serious complications after a certain type of heart attack (acute ST elevation anterior wall myocardial infarction [STEMI]) by evaluating the use of the TandemHeart system prior… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- TandemHeart System and Percutaneous coronary intervention
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Feb 2017
- Phase
- Interventional
- 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
- The following is a list of general inclusion criteria. More detailed information can be found in the study protocol.
- ≥ 18 years of age
- Presents within 6 hours of acute MI symptoms
- Evidence of ST elevation
- First myocardial infarction
- Written informed consent
Who cannot join
- The following is a list of general exclusion criteria. More detailed information can be found in the study protocol.
- Contraindications to antiplatelet/anticoagulation therapy
- History of blood disorders or active bleeding
- Renal dysfunction or failure
- Neurologic damage
- Cardiogenic shock
Show all 11Show fewer
- History of cerebrovascular disease
- History of transfusion reaction
- Prior coronary artery bypass surgery
- Participation in another trial with an investigational drug or device
- Pregnant
About this study
Official title: A Randomized Controlled Multicenter Study on the Use of the TandemHeart to Reduce Infarct Size
The purpose of this study is to determine if a device known as the TandemHeart® System (TandemHeart) can help limit heart damage and reduce serious complications after a certain type of heart attack (acute ST elevation anterior wall myocardial infarction [STEMI]) by evaluating the use of the TandemHeart system prior to a procedure called percutaneous coronary intervention (PCI)
- Conditions
- Acute Myocardial Infarction
- Being tested
- TandemHeart System, Percutaneous coronary intervention
- Keywords
- Myocardial infarction, STEMI, ST elevation MI, Acute MI
- Medical subject headings
- Myocardial Infarction, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TandemHeart SystemDevice
Percutaneous coronary interventionProcedure or surgery
Also called PCI
| Study group | Role | What they receive |
|---|---|---|
| TandemHeart System + PCI | Experimental | TandemHeart System prior to percutaneous coronary intervention Receives: Device: TandemHeart System; Procedure: Percutaneous coronary intervention |
| PCI | Active comparator | Percutaneous coronary intervention Receives: Procedure: Percutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety
Major Adverse Cardiac or Cerebrovascular Events (MACCE):
- Death, all cause
- Stroke
- Reinfarction
- Major vascular complications
Measured: 30 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2014 (estimated)
- Study startJan 2015
- Primary completionAug 2016 (estimated)
- Study completionFeb 2017 (estimated)
Why it stopped: No participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- CardiacAssist, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02164058
- Sponsor's protocol ID
- CA 2011-01
- Acronym
- TRIS
- Status last verified
- Dec 2015
- First submitted
- 12 Jun 2014
- Last updated
- 4 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Multicenter Study on the Use of the TandemHeart to Reduce Infarct Size
- ClinicalTrials.gov ID
- NCT02164058
- Acronym / sponsor ID
- TRIS / CA 2011-01
- Conditions
- Acute Myocardial Infarction
- Keywords
- Myocardial infarction, STEMI, ST elevation MI, Acute MI
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- CardiacAssist, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 16 Jun 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 purpose of this study is to determine if a device known as the TandemHeart® System (TandemHeart) can help limit heart damage and reduce serious complications after a certain type of heart attack (acute ST elevation anterior wall myocardial infarction [STEMI]) by evaluating the use of the TandemHeart system prior to a procedure called percutaneous coronary intervention (PCI)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TandemHeart System + PCI | Experimental | Device: TandemHeart System, Procedure: Percutaneous coronary interventionTandemHeart System prior to percutaneous coronary intervention |
| PCI | Active comparator | Procedure: Percutaneous coronary interventionPercutaneous coronary intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The following is a list of general inclusion criteria. More detailed information can be found in the study protocol.
- ≥ 18 years of age
- Presents within 6 hours of acute MI symptoms
- Evidence of ST elevation
- First myocardial infarction
Key exclusion criteria (11 listed)
- The following is a list of general exclusion criteria. More detailed information can be found in the study protocol.
- Contraindications to antiplatelet/anticoagulation therapy
- History of blood disorders or active bleeding
- Renal dysfunction or failure
- Neurologic damage
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 |
|---|---|---|
| TandemHeart System | Device | TandemHeart System + PCI |
| Percutaneous coronary interventionAlso: PCI | Procedure or surgery | PCI, TandemHeart System + PCI |
Primary outcome
Primary Safety
Time frame: 30 days post-procedure
Major Adverse Cardiac or Cerebrovascular Events (MACCE): * Death, all cause * Stroke * Reinfarction * Major vascular complications
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2015.
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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 study testing TandemHeart System and Percutaneous coronary intervention in people with Acute Myocardial Infarction, run by CardiacAssist, Inc..
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 11 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: withdrawn, as of the sponsor's last update on 4 Dec 2015. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Primary Safety (time frame: 30 days post-procedure). 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 4 Dec 2015.