Acute Myocardial Infarction (AMI)Phase 4CRISP-AMINCT00833612
Counterpulsation Reduces Infarct Size Pre-PCI for AMI
A Phase 4 study testing Counterpulsation with IAB in people with Acute Myocardial Infarction (AMI), run by Datascope Corp. at 40 sites in 10 countries.
Trial summary
Subjects with anterior acute STEMI who receive an IABC before primary PCI will have decreased MI size. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Myocardial Infarction (AMI)
- What is being tested?
- Counterpulsation with IAB
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 339 participants
- Where
- 40 sitesin 10 countries
- Study dates
- Dec 2008to Mar 2011
- Phase
- Phase 4
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to understand and sign an ICF
- ≥ 18 and ≤ 90 years of age
- General good health, in the opinion of the investigator
- ST elevation of 2mm in 2 contiguous anterior leads or ≥ 4mm total in anterior leads
- Scheduled for PCI < 6 hours from onset of symptoms of MI
Who cannot join
- Known contraindication to MRI
- Prior thrombolytic therapy during the index event
- Known history of MI
- Known severe aortic insufficiency
- Known aortic aneurysm
- Known severe calcific aorta-iliac disease or peripheral vascular disease
Show all 9Show fewer
- Experiencing cardiac shock
- Known end-stage renal disease
- Weight >400 lbs. or height <4 ft.
Trial locations and contacts
40 sites in 10 countries.
40 sites in 10 countries
United States16 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Tufts Medical Center
Boston, Massachusetts, 02111
Caritas St. Elizabeth's Medical Center
Boston, Massachusetts, 02135
Essentia Institute of Rural Health (St Mary's)
Duluth, Minnesota, 55805
Duke University Medical Center
Durham, North Carolina, 27705
University of Texas Health Science Center at Houston
Houston, Texas, 77030
Lancaster General Hospital
Lancaster, Pennsylvania, 17603
University of Southern California
Los Angeles, California, 90033
University of Medicine and Dentistry of New Jersey
Newark, New Jersey, 07103
Newark Beth Israel Hospital
Newark, New Jersey, 07112
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
University of Rochester Medical Center-Strong Memorial Hospital
Rochester, New York, 14627
Washington Hospital Center
Washington D.C., District of Columbia, 20010
Cleveland Clinic Florida
Weston, Florida, 33331
India11 sites
Saint John's Medical College and Hospital
Bangalore, Karnataka, 560034
Bhagwan Mahaveer Jain Heart Centre
Bangalore, 560052
Apollo Hospitals
Bangalore
Medanta - The Medicity
Delhi, 122 001
Gurunanak CARE Hospital
Hyderabad, Andhra Pradesh, 500020
CARE Hospital
Hyderabad, 50034
Tagore Hospital and Heart Care Centre
Jalandhar, 144 008
Indraprastha Apollo Hospital
New Delhi, 110044
Sir Gangaram Hospital
New Delhi, 110060
Baroda Heart Institute and Research Centre
Vadodara, Gujarat, 390 007
Apollo Gleneagles Hospital
West Bengal
United Kingdom4 sites
Royal Bournemouth Hospital
Dorset, BH7 7DW
Royal Infirmary of Edinburgh
Edinburgh, EH8 9RS
Leeds General Infirmary
Leeds, LS9 7TF
St. Thomas Hospital
London, SE1 7EH
Germany3 sites
Klinik fur Innere Medizin und Kardiologie
Dresden, 1307
University of Freiburg
Freiburg im Breisgau
Herzzentrum Leipzig GmbH
Leipzig, D-04289
About this study
Official title: A Multi-center, Randomized, Controlled Study of Mechanical Left Ventricular Unloading With Counterpulsation to Reduce Infarct Size Pre-PCI for Acute Myocardial Infarction - CRISP AMI
Subjects with anterior acute STEMI who receive an IABC before primary PCI will have decreased MI size.
Read the detailed description
Post clearance device study in which subjects with acute MI will be randomized 1:1 to either receive IAB or to receive standard of care without IAB before mechanical reperfusion. Subjects will be followed throughout their hospital stay and at 30 days.
- Conditions
- Acute Myocardial Infarction (AMI)
- Being tested
- Counterpulsation with IAB
- Keywords
- IABC, AMI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Counterpulsation with IABDevice
Also called CS100 & CS300 IAB Linear 7.5F Fidelity 8.0 F Sensation 7.0 F
IABC pre-reperfusion PCI
| Study group | Role | What they receive |
|---|---|---|
| Control arm of study | No intervention | Not described Receives: Device: Counterpulsation with IAB |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine whether IABC before mechanical reperfusion decreases myocardial infarct (MI) size.
Measured: 3-5 days
Secondary outcomes (1)
To determine the effect of IABC before mechanical reperfusion on post PCI cardiovascular function and major adverse cardiac events (MACE) (ie, death, reinfarction, and CHF) at 30 days and 6 months.
Measured: 30 days and 6 months post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2009 (estimated)
- Study startDec 2008
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial Infarction (AMI)Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 339 participants (actual)
Sponsor and investigators
- Lead sponsor
- Datascope Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Duke University, Flinders Medical Centre
- Investigators
- Magnus Ohman, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00833612
- Sponsor's protocol ID
- P00001
- Acronym
- CRISP-AMI
- Status last verified
- Jun 2011
- First submitted
- 27 Jan 2009
- Last updated
- 27 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Patel MR, Smalling RW, Thiele H, Barnhart HX, Zhou Y, Chandra P, Chew D, Cohen M, French J, Perera D, Ohman EM. Intra-aortic balloon counterpulsation and infarct size in patients with acute anterior myocardial infarction without shock: the CRISP AMI randomized trial. JAMA. 2011 Sep 28;306(12):1329-37. doi: 10.1001/jama.2011.1280. Epub 2011 Aug 29.
PubMed 21878431Patel MR, Thiele H, Smalling RW, Chandra P, Zhou Y, Cohen M, Perera D, Ohman EM. A multicenter, randomized, controlled study of mechanical left ventricular unloading with counterpulsation to reduce infarct size prepercutaneous coronary intervention for acute myocardial infarction: rationale and design of the Counterpulsation Reduces Infarct Size Acute Myocardial Infarction trial. Am Heart J. 2011 Jul;162(1):47-55.e1. doi: 10.1016/j.ahj.2011.03.037.
PubMed 21742089
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Controlled Study of Mechanical Left Ventricular Unloading With Counterpulsation to Reduce Infarct Size Pre-PCI for Acute Myocardial Infarction - CRISP AMI
- ClinicalTrials.gov ID
- NCT00833612
- Acronym / sponsor ID
- CRISP-AMI / P00001
- Conditions
- Acute Myocardial Infarction (AMI)
- Keywords
- IABC, AMI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 339 participants (actual)
- Lead sponsor
- Datascope Corp.Industry (pharma, biotech, devices)
- Collaborators
- Duke University, Flinders Medical Centre
- Study start
- Dec 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 2 Feb 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.
Subjects with anterior acute STEMI who receive an IABC before primary PCI will have decreased MI size.
Detailed description
Post clearance device study in which subjects with acute MI will be randomized 1:1 to either receive IAB or to receive standard of care without IAB before mechanical reperfusion. Subjects will be followed throughout their hospital stay and at 30 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Control arm of study | No intervention | Device: Counterpulsation with IAB |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Able to understand and sign an ICF
- ≥ 18 and ≤ 90 years of age
- General good health, in the opinion of the investigator
- ST elevation of 2mm in 2 contiguous anterior leads or ≥ 4mm total in anterior leads
- Scheduled for PCI < 6 hours from onset of symptoms of MI
Key exclusion criteria (9 listed)
- Known contraindication to MRI
- Prior thrombolytic therapy during the index event
- Known history of MI
- Known severe aortic insufficiency
- Known aortic aneurysm
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 |
|---|---|---|
| Counterpulsation with IABAlso: CS100 & CS300 IAB Linear 7.5F Fidelity 8.0 F Sensation 7.0 FIABC pre-reperfusion PCI | Device | Control arm of study |
Primary outcome
To determine whether IABC before mechanical reperfusion decreases myocardial infarct (MI) size.
Time frame: 3-5 days
1 secondary outcome
To determine the effect of IABC before mechanical reperfusion on post PCI cardiovascular function and major adverse cardiac events (MACE) (ie, death, reinfarction, and CHF) at 30 days and 6 months.
Time frame: 30 days and 6 months post randomization
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 27 Jun 2011.
- Derived from this study: PubMed 21878431Patel MR, Smalling RW, Thiele H, Barnhart HX, Zhou Y, Chandra P, Chew D, Cohen M, French J, Perera D, Ohman EM. Intra-aortic balloon counterpulsation and infarct size in patients with acute anterior myocardial infarction without shock: the CRISP AMI randomized trial. JAMA. 2011 Sep 28;306(12):1329-37. doi: 10.1001/jama.2011.1280. Epub 2011 Aug 29.
- Derived from this study: PubMed 21742089Patel MR, Thiele H, Smalling RW, Chandra P, Zhou Y, Cohen M, Perera D, Ohman EM. A multicenter, randomized, controlled study of mechanical left ventricular unloading with counterpulsation to reduce infarct size prepercutaneous coronary intervention for acute myocardial infarction: rationale and design of the Counterpulsation Reduces Infarct Size Acute Myocardial Infarction trial. Am Heart J. 2011 Jul;162(1):47-55.e1. doi: 10.1016/j.ahj.2011.03.037.
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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.
Magnus Ohman, MD principal investigator
Duke University
40 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Counterpulsation with IAB in people with Acute Myocardial Infarction (AMI), run by Datascope Corp. at 40 sites in 10 countries.
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 5 inclusion and 9 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 27 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States, India, United Kingdom, Germany, Australia and 5 more countries. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
To determine whether IABC before mechanical reperfusion decreases myocardial infarct (MI) size. (time frame: 3-5 days). 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 NCT00833612, which also lists 2 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 27 Jun 2011.