Chest PainPROMISE-SAFERNCT01890525
PROMISE Substudy to Assess For Effective Dose of Radiation (PROMISE-SAFER) Specific Aim 3b
An observational study of Chest Pain and Coronary Artery Disease, run by Kaiser Permanente at 1 site in United States.
Trial summary
The purpose of this study is to compare different methods of collecting the amount of radiation exposure patients receive in a clinical study. As part of the PROMISE study, the Duke Clinical Research Institute Outcomes and Follow-up Group will be contacting patients every six months to ask if they had any heart… Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Chest Pain, Coronary Artery Disease, Angina
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2012to 15 Oct 2019
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: PROMISE study patients
Who may be able to join
None listed.
Who cannot join
- Diagnosed or suspected acute coronary syndrome requiring hospitalization or urgent or emergent testing; Elevated troponin or creatinine kinase-MB
- Hemodynamically or clinically unstable condition (systolic blood pressure < 90 mmHg, atrial or ventricular arrhythmias, or persistent resting chest pain felt to be ischemic despite adequate therapy)
- Known coronary artery disease with prior myocardial infarction, percutaneous coronary intervention, coronary artery bypass grafting or any angiographic evidence of coronary artery disease ≥50% lesion in a major epicardial vessel.
- Any invasive coronary angiography or non-invasive anatomic or functional cardiovascular test for detection of coronary artery disease, including coronary computed tomographic angiography and exercise electrocardiogram, within the previous twelve (12) months.
- Known significant congenital, valvular (> moderate) or cardiomyopathic process (hypertrophic cardiomyopathy or reduced systolic left ventricular function (left ventricular ejection fraction ≤ 40%)) which could explain cardiac symptoms.
- Contraindication to undergoing a coronary computed tomographic angiography, including but not limited to:
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- Pregnancy or breastfeeding
- Life expectancy < 2 years
- Unable to provide written informed consent or participate in long-term follow-up
Trial locations and contacts
1 site in 1 country.
United States1 site
San Jose Medical Center - Kaiser Permanente
San Jose, California, 95119
About this study
Official title: PROMISE Substudy to Assess For Effective Dose of Radiation (PROMISE-SAFER), Specific Aim 3b
The purpose of this study is to compare different methods of collecting the amount of radiation exposure patients receive in a clinical study. As part of the PROMISE study, the Duke Clinical Research Institute Outcomes and Follow-up Group will be contacting patients every six months to ask if they had any heart procedures or testing. This information will be used to estimate the amount of radiation that they may have received from heart testing being studied in this study, PROMISE-SAFER. Patients will be asked to collect information about each heart testing they receive during the time that they are enrolled in the PROMISE study. At the conclusion of the study, we will be able to determine which method was most accurate in collecting the amount of radiation exposure for this clinical study. Through this study we hope to develop an improved methodology to estimate cumulative radiation exposure from cardiac imaging. Comprehensive measurement of cumulative radiation exposure to patients may be critically important to minimize potential harm in future studies and in clinical practice.
- Conditions
- Chest Pain, Coronary Artery Disease, Angina
- Keywords
- radiation
- Medical subject headings
- Chest Pain, Coronary Artery Disease, Angina Pectoris
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 |
|---|---|---|
| PROMISE study patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Methods to measure cumulative radiation exposure from a cardiac imaging trial will be compared to radiation measurements from the "gold standard" electronic medical records
In a single site (San Jose Medical Center - Kaiser Permanente) at a health maintenance organization where patients undergo all testing on site and comprehensive radiation records are maintained, 3 approaches to obtaining follow-up radiation dosimetry estimates will be compared: 1) the standard method used at all sites of combining those procedures identified on follow-up surveys with measured or imputed procedure dose estimates, 2) Radiation Log forms that patients will receive and will be asked to complete whenever they undergo further imaging, and 3) "gold standard" review of patient electronic medical records to identify all procedures with ionizing radiation and measured dose estimates from each procedure.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2013 (estimated)
- Study start1 Aug 2012
- Primary completion15 Aug 2016
- Study completion15 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest PainStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University
- Responsible party
- Sponsor
- Investigators
- James J Jang, MD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01890525
- Sponsor's protocol ID
- R01HL109711-01
- Acronym
- PROMISE-SAFER
- Status last verified
- Dec 2019
- First submitted
- 9 Apr 2013
- Last updated
- 6 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROMISE Substudy to Assess For Effective Dose of Radiation (PROMISE-SAFER), Specific Aim 3b
- ClinicalTrials.gov ID
- NCT01890525
- Acronym / sponsor ID
- PROMISE-SAFER / R01HL109711-01
- Conditions
- Chest Pain, Coronary Artery Disease, Angina
- Keywords
- radiation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- Columbia University
- Study start
- 1 Aug 2012 (actual)
- Primary completion
- 15 Aug 2016 (actual)
- Study completion
- 15 Oct 2019 (actual)
- First posted
- 1 Jul 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.
The purpose of this study is to compare different methods of collecting the amount of radiation exposure patients receive in a clinical study. As part of the PROMISE study, the Duke Clinical Research Institute Outcomes and Follow-up Group will be contacting patients every six months to ask if they had any heart procedures or testing. This information will be used to estimate the amount of radiation that they may have received from heart testing being studied in this study, PROMISE-SAFER. Patients will be asked to collect information about each heart testing they receive during the time that they are enrolled in the PROMISE study. At the conclusion of the study, we will be able to determine which method was most accurate in collecting the amount of radiation exposure for this clinical study. Through this study we hope to develop an improved methodology to estimate cumulative radiation exposure from cardiac imaging. Comprehensive measurement of cumulative radiation exposure to patients may be critically important to minimize potential harm in future studies and in clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PROMISE study patients | – | – |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- PROMISE study patients
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- Diagnosed or suspected acute coronary syndrome requiring hospitalization or urgent or emergent testing; Elevated troponin or creatinine kinase-MB
- Hemodynamically or clinically unstable condition (systolic blood pressure < 90 mmHg, atrial or ventricular arrhythmias, or persistent resting chest pain felt to be ischemic despite adequate therapy)
- Known coronary artery disease with prior myocardial infarction, percutaneous coronary intervention, coronary artery bypass grafting or any angiographic evidence of coronary artery disease ≥50% lesion in a major epicardial vessel.
- Any invasive coronary angiography or non-invasive anatomic or functional cardiovascular test for detection of coronary artery disease, including coronary computed tomographic angiography and exercise electrocardiogram, within the previous twelve (12) months.
- Known significant congenital, valvular (> moderate) or cardiomyopathic process (hypertrophic cardiomyopathy or reduced systolic left ventricular function (left ventricular ejection fraction ≤ 40%)) which could explain cardiac symptoms.
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
Methods to measure cumulative radiation exposure from a cardiac imaging trial will be compared to radiation measurements from the "gold standard" electronic medical records
Time frame: 4 years
In a single site (San Jose Medical Center - Kaiser Permanente) at a health maintenance organization where patients undergo all testing on site and comprehensive radiation records are maintained, 3 approaches to obtaining follow-up radiation dosimetry estimates will be compared: 1) the standard method used at all sites of combining those procedures identified on follow-up surveys with measured or imputed procedure dose estimates, 2) Radiation Log forms that patients will receive and will be asked to complete whenever they undergo further imaging, and 3) "gold standard" review of patient electronic medical records to identify all procedures with ionizing radiation and measured dose estimates from each procedure.
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 6 Dec 2019.
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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.
James J Jang, MD principal investigator
Kaiser Permanente
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 Chest Pain and Coronary Artery Disease, run by Kaiser Permanente 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 0 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 6 Dec 2019. 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?
Methods to measure cumulative radiation exposure from a cardiac imaging trial will be compared to radiation measurements from the "gold standard" electronic medical records (time frame: 4 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 6 Dec 2019.