Microvascular AnginaCIAONCT02347215
Changes in Ischemia and Angina Over 1 Year Among ISCHEMIA Trial Screen Failures With no Obstructive CAD on Coronary CT Angiography
A study testing Quality of Life assessment and Stress imaging in people with Microvascular Angina and Angina Pectoris, run by NYU Langone Health at 1 site in United States.
Trial summary
Serial assessment of angina status and ischemia on stress echo over one year among patients with moderate ischemia on stress imaging and non-obstructive CAD on coronary CT angiography. Read more about this study
- Who is it for?
- Ages 21 to 100 years
- Conditions the study is for
- Microvascular Angina, Angina Pectoris
- What is being tested?
- Quality of Life assessment and Stress imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Dec 2019
- 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 21 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Enrolled but not randomized in ISCHEMIA trial
- Stress echocardiography used for enrollment*
- No obstructive CAD on study coronary CT angiography (defined as no ≥50% stenosis in a major epicardial vessel)
- Ischemic symptoms (chest pain or other potential ischemic equivalent).
- Participant is willing to give written informed consent
- Age ≥ 21 years
Who cannot join
- Inability to comply with protocol
- Prior PCI or CABG
Trial locations and contacts
1 site in 1 country.
United States1 site
NYU Medical Center and Bellevue Hospital Center
New York, New York, 10016
About this study
Official title: Changes in Ischemia and Angina Over One Year Among ISCHEMIA Trial Screen Failures
Serial assessment of angina status and ischemia on stress echo over one year among patients with moderate ischemia on stress imaging and non-obstructive CAD on coronary CT angiography.
Read the detailed description
Some people with chest pain are found to have open arteries on angiograms instead of blocked arteries and many, but not all, of these people have abnormal stress tests or other tests showing there is not enough blood flow to the heart. Prior research has not made clear whether chest pain in such patients is due to heart disease or something else, in part because no one has found out whether chest pain and stress test results change in the same direction over time. This study will use two measurements of chest pain and two stress tests, one year apart, to find out if chest pain and abnormal stress tests are both caused by the same problem: not enough blood flow to the heart.The association between angina, ischemia and atherosclerosis severity at baseline will be examined, as will medication effects.
- Conditions
- Microvascular Angina, Angina Pectoris
- Being tested
- Quality of Life assessment, Stress imaging
- Medical subject headings
- Microvascular Angina, Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of Life assessmentOther
Seattle Angina Questionnaire and other questionnaires.
Stress imagingProcedure or surgery
Stress imaging
| Study group | Role | What they receive |
|---|---|---|
| All patients | Other | All patients undergo quality of life assessment at 2-3 time points and stress imaging at two time points Receives: Other: Quality of Life assessment; Procedure: Stress imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seattle Angina Questionnaire (SAQ) score
Measured: baseline-one year comparison
Secondary outcomes (5)
Ischemia severity
Measured: baseline-one year comparison
Coronary atherosclerosis severity (comparison with SAQ score and with ischemia severity)
comparison with SAQ score and with ischemia severity
Measured: baseline
Ischemia severity (comparison with SAQ score and with ischemia severity)
comparison with SAQ score and with atherosclerosis severity
Measured: baseline
Medical therapy used for angina (comparison with SAQ score and ischemia severity)
comparison with SAQ score and ischemia severity
Measured: one year
Major adverse cardiac events
death, MI, stroke, cardiovascular hospitalizations/ER visits
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2015 (estimated)
- Study startAug 2014
- Primary completionDec 2019
- Study completionDec 2019
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 Microvascular AnginaStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Duke Clinical Research Institute, Massachusetts General Hospital
- Responsible party
- Sponsor
- Investigators
- Judith Hochman, MD, Principal investigator, New York Langone Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02347215
- Sponsor's protocol ID
- s11-00498
- Acronym
- CIAO
- Status last verified
- Feb 2020
- First submitted
- 14 Jan 2015
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hausvater A, Anthopolos R, Seltzer A, Spruill TM, Spertus JA, Peteiro J, Lopez-Sendon JL, Celutkiene J, Demchenko EA, Kedev S, Beleslin BD, Sidhu MS, Grodzinsky A, Fleg JL, Maron DJ, Hochman JS, Reynolds HR; CIAO-ISCHEMIA Research Group. Sex Differences in Psychosocial Factors and Angina in Patients With Chronic Coronary Disease. J Am Heart Assoc. 2025 Mar 4;14(5):e037909. doi: 10.1161/JAHA.124.037909. Epub 2025 Feb 25.
PubMed 39996455Reynolds HR, Picard MH, Spertus JA, Peteiro J, Lopez Sendon JL, Senior R, El-Hajjar MC, Celutkiene J, Shapiro MD, Pellikka PA, Kunichoff DF, Anthopolos R, Alfakih K, Abdul-Nour K, Khouri M, Bershtein L, De Belder M, Poh KK, Beltrame JF, Min JK, Fleg JL, Li Y, Maron DJ, Hochman JS. Natural History of Patients With Ischemia and No Obstructive Coronary Artery Disease: The CIAO-ISCHEMIA Study. Circulation. 2021 Sep 28;144(13):1008-1023. doi: 10.1161/CIRCULATIONAHA.120.046791. Epub 2021 Jun 1.
PubMed 34058845
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Ischemia and Angina Over One Year Among ISCHEMIA Trial Screen Failures
- ClinicalTrials.gov ID
- NCT02347215
- Acronym / sponsor ID
- CIAO / s11-00498
- Conditions
- Microvascular Angina, Angina Pectoris
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Duke Clinical Research Institute, Massachusetts General Hospital
- Study start
- Aug 2014 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 27 Jan 2015 (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.
Serial assessment of angina status and ischemia on stress echo over one year among patients with moderate ischemia on stress imaging and non-obstructive CAD on coronary CT angiography.
Detailed description
Some people with chest pain are found to have open arteries on angiograms instead of blocked arteries and many, but not all, of these people have abnormal stress tests or other tests showing there is not enough blood flow to the heart. Prior research has not made clear whether chest pain in such patients is due to heart disease or something else, in part because no one has found out whether chest pain and stress test results change in the same direction over time. This study will use two measurements of chest pain and two stress tests, one year apart, to find out if chest pain and abnormal stress tests are both caused by the same problem: not enough blood flow to the heart.The association between angina, ischemia and atherosclerosis severity at baseline will be examined, as will medication effects.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | Other | Other: Quality of Life assessment, Procedure: Stress imagingAll patients undergo quality of life assessment at 2-3 time points and stress imaging at two time points |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Enrolled but not randomized in ISCHEMIA trial
- Stress echocardiography used for enrollment*
- No obstructive CAD on study coronary CT angiography (defined as no ≥50% stenosis in a major epicardial vessel)
- Ischemic symptoms (chest pain or other potential ischemic equivalent).
- Participant is willing to give written informed consent
Key exclusion criteria (2 listed)
- Inability to comply with protocol
- Prior PCI or CABG
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 |
|---|---|---|
| Quality of Life assessmentSeattle Angina Questionnaire and other questionnaires. | Other | All patients |
| Stress imagingStress imaging | Procedure or surgery | All patients |
Primary outcome
Seattle Angina Questionnaire (SAQ) score
Time frame: baseline-one year comparison
5 secondary outcomes
Ischemia severity
Time frame: baseline-one year comparison
Coronary atherosclerosis severity (comparison with SAQ score and with ischemia severity)
Time frame: baseline
Ischemia severity (comparison with SAQ score and with ischemia severity)
Time frame: baseline
Medical therapy used for angina (comparison with SAQ score and ischemia severity)
Time frame: one year
Major adverse cardiac events
Time frame: one year
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 17 Feb 2020.
- Derived from this study: PubMed 39996455Hausvater A, Anthopolos R, Seltzer A, Spruill TM, Spertus JA, Peteiro J, Lopez-Sendon JL, Celutkiene J, Demchenko EA, Kedev S, Beleslin BD, Sidhu MS, Grodzinsky A, Fleg JL, Maron DJ, Hochman JS, Reynolds HR; CIAO-ISCHEMIA Research Group. Sex Differences in Psychosocial Factors and Angina in Patients With Chronic Coronary Disease. J Am Heart Assoc. 2025 Mar 4;14(5):e037909. doi: 10.1161/JAHA.124.037909. Epub 2025 Feb 25.
- Derived from this study: PubMed 34058845Reynolds HR, Picard MH, Spertus JA, Peteiro J, Lopez Sendon JL, Senior R, El-Hajjar MC, Celutkiene J, Shapiro MD, Pellikka PA, Kunichoff DF, Anthopolos R, Alfakih K, Abdul-Nour K, Khouri M, Bershtein L, De Belder M, Poh KK, Beltrame JF, Min JK, Fleg JL, Li Y, Maron DJ, Hochman JS. Natural History of Patients With Ischemia and No Obstructive Coronary Artery Disease: The CIAO-ISCHEMIA Study. Circulation. 2021 Sep 28;144(13):1008-1023. doi: 10.1161/CIRCULATIONAHA.120.046791. Epub 2021 Jun 1.
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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.
Judith Hochman, MD principal investigator
New York Langone Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quality of Life assessment and Stress imaging in people with Microvascular Angina and Angina Pectoris, run by NYU Langone Health 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 6 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: finished, as of the sponsor's last update on 17 Feb 2020. 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?
Seattle Angina Questionnaire (SAQ) score (time frame: baseline-one year comparison). 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 NCT02347215, 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 17 Feb 2020.