Cardiovascular AbnormalitiesNCT02025101
Characterization of Slow Coronary Flow
An observational study of Cardiovascular Abnormalities and Vascular Diseases, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
Description of the phenomena "Slow Coronary Flow" (SCF), according to the data that has been collected from patients hospitalized with specific criteria. Clinical follow-up of these patients to determine whether they suffered from any cardial or psychological disorders that might be a result of SCF. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Cardiovascular Abnormalities, Vascular Diseases
- How many people
- 90 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2014to Dec 2014
- Phase
- Observational
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who were hospitalized with anginal pain
Who may be able to join
- anginal pain
- laboratory markers
- pathological ECG for ischemia
Who cannot join
- obstructed coronary artery during catheterization
- very narrow coronary artery
Trial locations and contacts
1 site in 1 country.
About this study
Description of the phenomena "Slow Coronary Flow" (SCF), according to the data that has been collected from patients hospitalized with specific criteria. Clinical follow-up of these patients to determine whether they suffered from any cardial or psychological disorders that might be a result of SCF.
- Conditions
- Cardiovascular Abnormalities, Vascular Diseases
- Keywords
- Slow Coronary Flow
- Medical subject headings
- Cardiovascular Abnormalities, Vascular Diseases
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 |
|---|---|---|
| Slow Coronary Flow | Patients who were hospitalized with anginal pain and with laboratory markers or pathological ECG for ischemia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of characteristics of slow coronary flow from approximately 90 patient records
Characteristics of slow coronary flow will be collected from approximately 90 patient medical records and will analyzed to find the common variables. This analysis will show whether there is any statistical significance to these characteristics.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionJul 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular AbnormalitiesStudies 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
- Case only
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Aaron Frimerman, MD, Principal investigator, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02025101
- Sponsor's protocol ID
- 0048-13-HYMC
- Status last verified
- Dec 2013
- First submitted
- 29 Dec 2013
- Last updated
- 31 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Slow Coronary Flow
- ClinicalTrials.gov ID
- NCT02025101
- Acronym / sponsor ID
- 0048-13-HYMC
- Conditions
- Cardiovascular Abnormalities, Vascular Diseases
- Keywords
- Slow Coronary Flow
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Jan 2014
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 31 Dec 2013 (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.
Description of the phenomena "Slow Coronary Flow" (SCF), according to the data that has been collected from patients hospitalized with specific criteria. Clinical follow-up of these patients to determine whether they suffered from any cardial or psychological disorders that might be a result of SCF.
Study design
- Observational model
- Case only
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Slow Coronary Flow | – | –Patients who were hospitalized with anginal pain and with laboratory markers or pathological ECG for ischemia. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were hospitalized with anginal pain
Key inclusion criteria (3 listed)
- anginal pain
- laboratory markers
- pathological ECG for ischemia
Key exclusion criteria (2 listed)
- obstructed coronary artery during catheterization
- very narrow coronary artery
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
Collection of characteristics of slow coronary flow from approximately 90 patient records
Time frame: Six months
Characteristics of slow coronary flow will be collected from approximately 90 patient medical records and will analyzed to find the common variables. This analysis will show whether there is any statistical significance to these characteristics.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2013.
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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.
Aaron Frimerman, MD principal investigator
Hillel Yaffe Medical Center
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 Cardiovascular Abnormalities and Vascular Diseases, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 31 Dec 2013. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meni Amran, B.Sc. (972-505-679225, meni.amran@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collection of characteristics of slow coronary flow from approximately 90 patient records (time frame: Six months). 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 31 Dec 2013.