Acute Coronary SyndromeNCT01500902
Prediction of Cardiovascular Events in Vulnerable Patients Following Acute Coronary Syndrome
A study testing EndoPAT testing (non invasive device) and WatchPAT testing (non-invasive device) in people with Acute Coronary Syndrome, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to determine if testing patients for endothelial dysfunction will help identify which patients are more likely at risk to have another heart attack in the future. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- EndoPAT testing (non invasive device) and WatchPAT testing (non-invasive device)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Apr 2015
- 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
- Patients undergoing revascularization by percutaneous intervention (PCI) for Acute Coronary Syndrome (ACS) at Mayo (STEMI and NonSTEMI patients)
- Age greater than 18
Who cannot join
- Patients likely not to complete the study due to co-morbid conditions (end stage renal disease; liver failure; malignancies)
- Inability to sign a consent form or availability for follow up
- Patients unable to tolerate the blood pressure cuff inflation on both arms
- patients with tremors
- sustained non-sinus cardiac arrhythmias
- acrylic finger nails
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- permanent pacemaker
- color blindness
- use of alpha blockers and short acting nitrates < 3 hours before study
- Federal Medical Center inmates
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Assessment of Novel Functional Risk Factors for the Prediction of Cardiovascular Events in Vulnerable Patients Following Acute Coronary Syndrome
The purpose of this study is to determine if testing patients for endothelial dysfunction will help identify which patients are more likely at risk to have another heart attack in the future. Study participants will undergo mental stress testing while at the same time being connected to a device that measures endothelial function via the Endopat device. These same participants will also undergo a sleep study via the Watchpat device.
- Conditions
- Acute Coronary Syndrome
- Being tested
- EndoPAT testing (non invasive device), WatchPAT testing (non-invasive device)
- Keywords
- Acute Coronary Syndrome (ACS), Percutaneous Intervention (PCI), Coronary Stent (CStent), Percutaneous Transluminal Coronary Angioplasty (PTCA), stent placement, balloon angioplasty
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoPAT testing (non invasive device)Other
Also called Itamar EndoPAT 2000
Using the EndoPAT device, we will assess endothelial function.
WatchPAT testing (non-invasive device)Other
Also called Itamar WatchPAT 200
Using the WATCHPAT device we will assess sleep apnea.
| Study group | Role | What they receive |
|---|---|---|
| vascular testing | Other | We are assessing vascular testing in patients presenting with acute coronary syndrome to determine if this type of testing will help identify which patients are more likely at risk to have another heart attack. Receives: Other: EndoPAT testing (non invasive device); Other: WatchPAT testing (non-invasive device) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unstable Angina, Myocardial Infarction, Repeat Revascularization, Cardiac Death, Stroke
Measured: Will determine with statistical analysis after all patients have had 2 year follow-up
Secondary outcomes (1)
Quality of Life
Quality of Life as assessed by SF12
Measured: 6 months post revascularization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2011 (estimated)
- Study startSep 2011
- Primary completionMar 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Qatar National Research Fund
- Responsible party
- Principal investigator, Amir Lerman, Mayo Clinic
- Investigators
- Amir Lerman, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01500902
- Sponsor's protocol ID
- 09-000047
- Status last verified
- Sep 2015
- First submitted
- 22 Nov 2011
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Assessment of Novel Functional Risk Factors for the Prediction of Cardiovascular Events in Vulnerable Patients Following Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT01500902
- Acronym / sponsor ID
- 09-000047
- Conditions
- Acute Coronary Syndrome
- Keywords
- Acute Coronary Syndrome (ACS), Percutaneous Intervention (PCI), Coronary Stent (CStent), Percutaneous Transluminal Coronary Angioplasty (PTCA), stent placement, balloon angioplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Qatar National Research Fund
- Study start
- Sep 2011
- Primary completion
- Mar 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 29 Dec 2011 (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 testing patients for endothelial dysfunction will help identify which patients are more likely at risk to have another heart attack in the future. Study participants will undergo mental stress testing while at the same time being connected to a device that measures endothelial function via the Endopat device. These same participants will also undergo a sleep study via the Watchpat device.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| vascular testing | Other | Other: EndoPAT testing (non invasive device), Other: WatchPAT testing (non-invasive device)We are assessing vascular testing in patients presenting with acute coronary syndrome to determine if this type of testing will help identify which patients are more likely at risk to have another heart attack. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing revascularization by percutaneous intervention (PCI) for Acute Coronary Syndrome (ACS) at Mayo (STEMI and NonSTEMI patients)
- Age greater than 18
Key exclusion criteria (10 listed)
- Patients likely not to complete the study due to co-morbid conditions (end stage renal disease; liver failure; malignancies)
- Inability to sign a consent form or availability for follow up
- Patients unable to tolerate the blood pressure cuff inflation on both arms
- patients with tremors
- sustained non-sinus cardiac arrhythmias
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 |
|---|---|---|
| EndoPAT testing (non invasive device)Also: Itamar EndoPAT 2000Using the EndoPAT device, we will assess endothelial function. | Other | vascular testing |
| WatchPAT testing (non-invasive device)Also: Itamar WatchPAT 200Using the WATCHPAT device we will assess sleep apnea. | Other | vascular testing |
Primary outcome
Unstable Angina, Myocardial Infarction, Repeat Revascularization, Cardiac Death, Stroke
Time frame: Will determine with statistical analysis after all patients have had 2 year follow-up
1 secondary outcome
Quality of Life
Time frame: 6 months post revascularization.
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 23 Sep 2015.
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Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
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Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
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Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease
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.
Amir Lerman, M.D. 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 study testing EndoPAT testing (non invasive device) and WatchPAT testing (non-invasive device) in people with Acute Coronary Syndrome, 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 2 inclusion and 10 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 23 Sep 2015. 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?
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?
Unstable Angina, Myocardial Infarction, Repeat Revascularization, Cardiac Death, Stroke (time frame: Will determine with statistical analysis after all patients have had 2 year follow-up). 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 23 Sep 2015.