Acute Myocardial InfarctionCECNCT01005485
Molecular and Morphologic Characterization of Circulating Endothelial Cells
An observational study of Acute Myocardial Infarction, run by Scripps Translational Science Institute at 1 site in United States.
Trial summary
The primary hypothesis of this study is that circulating endothelial cells (CECs) harbor key genetic and structural characteristics predisposing individuals to acute atherosclerotic plaque rupture and heart attack. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Myocardial Infarction
- How many people
- 664 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects will be recruited from the general in-patient and out-patient populations for myocardial infarction and/or vascular surgery. Healthy controls will be recruited from the general medical population and community.
Who may be able to join
- Age 18 - 80 years old.
- Must be reliable, cooperative and willing to comply with all protocol-specified procedures if consented.
- Able to understand and grant informed consent
- Subjects must meet one of the following (a-c):
- Healthy control subjects not meeting any exclusion criteria for controls below
- Patients scheduled for an open vascular procedure of an arterial structure
- Patients with acute MI defined as:
- Clinical history and symptoms consistent with acute MI AND ii Elevated cardiac markers (CKMB, Troponin I or T) consistent with MI (abnormals are according to enrolling institution's lab standards) AND iii. Able to complete study enrollment (consent \& blood draw) within 48 hours of presentation to the study site.
Who cannot join
- General Exclusion Criteria:
- 1. Has a significant medical condition that in the investigator's opinion may interfere with the patient's optimal participation in the study.
- Age greater than 35
- Previous history of coronary artery disease or MI
- Diabetes
- Peripheral arterial disease
Show all 11Show fewer
- Hypertension (>140/90 or on blood pressure medication)
- Sickle cell disease
- Acute or Chronic kidney disease
- Acute or Chronic vascular conditions, not otherwise specified
- Active or history of inflammation of connective tissue and vascular structures (i.e. vasculitis, rheumatoid arthritis)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comprehensive Molecular and Morphologic Characterization of Circulating Endothelial Cells
The primary hypothesis of this study is that circulating endothelial cells (CECs) harbor key genetic and structural characteristics predisposing individuals to acute atherosclerotic plaque rupture and heart attack.
Read the detailed description
Endothelial injury and inflammation are pivotal underlying processes that put patients at risk for catastrophic vascular events including acute myocardial infarction (heart attack) and stroke. We seek to accelerate scientific discovery through clinically meaningful, innovative translational research, and are collaborating in a trans-disciplinary effort to define the DNA sequence of CECs and that of germ line DNA, along with RNA sequencing, mRNA expression profiling, and ultrastructural characterization of CECs in order to better understand the mechanisms leading to acute arterial plaque rupture and embolization of arterial endothelial cells in patients with acute myocardial infarction. This will enable us to create a molecular fingerprint that could identify and preempt individuals from suffering from such debilitating vascular conditions.
- Conditions
- Acute Myocardial Infarction
- Keywords
- Myocardial Infarction (MI), Circulating Endothelial Cells (CEC), Control Group A: (Vascular Surgery), Control Group B: (Healthy controls)
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Patients undergoing open vascular surgery on arterial structures to better define optimal laboratory and collection techniques for isolation of CECs. | |
| Group B | Healthy controls will be recruited from the general medical population, community. | |
| Acute Myocardial Infarction | Patients with acute myocardial infarction with or without ST segment deviation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is complete molecular profiling of CEC's in up to 250 patients with a diagnosis of acute myocardial infarction (MI) and up to 25 healthy controls.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2009 (estimated)
- Study startJan 2010
- Primary completionApr 2017
- Study completionDec 2025 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 664 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scripps Translational Science Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Topol, MD, Scripps Translational Science Institute
- Investigators
- Eric Topol, M.D., Principal investigator, Scripps Translational Science Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01005485
- Sponsor's protocol ID
- IRB#09-5287
- Acronym
- CEC
- Status last verified
- Jan 2025
- First submitted
- 29 Oct 2009
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Molecular and Morphologic Characterization of Circulating Endothelial Cells
- ClinicalTrials.gov ID
- NCT01005485
- Acronym / sponsor ID
- CEC / IRB#09-5287
- Conditions
- Acute Myocardial Infarction
- Keywords
- Myocardial Infarction (MI), Circulating Endothelial Cells (CEC), Control Group A: (Vascular Surgery), Control Group B: (Healthy controls)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 664 participants (actual)
- Lead sponsor
- Scripps Translational Science InstituteUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Apr 2017 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 2 Nov 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.
The primary hypothesis of this study is that circulating endothelial cells (CECs) harbor key genetic and structural characteristics predisposing individuals to acute atherosclerotic plaque rupture and heart attack.
Detailed description
Endothelial injury and inflammation are pivotal underlying processes that put patients at risk for catastrophic vascular events including acute myocardial infarction (heart attack) and stroke. We seek to accelerate scientific discovery through clinically meaningful, innovative translational research, and are collaborating in a trans-disciplinary effort to define the DNA sequence of CECs and that of germ line DNA, along with RNA sequencing, mRNA expression profiling, and ultrastructural characterization of CECs in order to better understand the mechanisms leading to acute arterial plaque rupture and embolization of arterial endothelial cells in patients with acute myocardial infarction. This will enable us to create a molecular fingerprint that could identify and preempt individuals from suffering from such debilitating vascular conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –Patients undergoing open vascular surgery on arterial structures to better define optimal laboratory and collection techniques for isolation of CECs. |
| Group B | – | –Healthy controls will be recruited from the general medical population, community. |
| Acute Myocardial Infarction | – | –Patients with acute myocardial infarction with or without ST segment deviation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be recruited from the general in-patient and out-patient populations for myocardial infarction and/or vascular surgery. Healthy controls will be recruited from the general medical population and community.
Key inclusion criteria (8 listed)
- Age 18 - 80 years old.
- Must be reliable, cooperative and willing to comply with all protocol-specified procedures if consented.
- Able to understand and grant informed consent
- Subjects must meet one of the following (a-c):
Key exclusion criteria (11 listed)
- 1. Has a significant medical condition that in the investigator's opinion may interfere with the patient's optimal participation in the study.
- Age greater than 35
- Previous history of coronary artery disease or MI
- Diabetes
- Peripheral arterial disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary endpoint is complete molecular profiling of CEC's in up to 250 patients with a diagnosis of acute myocardial infarction (MI) and up to 25 healthy controls.
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
Related trials for Acute Myocardial Infarction
Recruiting
CRP Apheresis in Infarct-Related Cardiogenic Shock
Cardiogenic Shock, Acute Myocardial Infarction (AMI)
Enrolling by invitationPhase 3
Selatogrel Outcome Study in Suspected Acute Myocardial Infarction
Acute Myocardial Infarction
RecruitingObservational study
Cardiogenic Shock Working Group Registry
Cardiogenic Shock
RecruitingObservational study
Assessment of Support With Impella® Best Practices in Acute Myocardial Infarction Complicated by Cardiogenic Shock
AMI Cardiogenic Shock
RecruitingObservational study
Changes in Skeletal Muscle Thickness in Patients With Acute Heart Failure
Heart Failure, Muscle Atrophy
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.
Eric Topol, M.D. principal investigator
Scripps Translational Science Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myocardial Infarction, run by Scripps Translational Science Institute 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 8 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: under way, not looking for participants, as of the sponsor's last update on 17 Jan 2025. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
The primary endpoint is complete molecular profiling of CEC's in up to 250 patients with a diagnosis of acute myocardial infarction (MI) and up to 25 healthy controls. (time frame: 2 years). 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 17 Jan 2025.