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Changes in Ischemia and Angina Over 1 Year Among ISCHEMIA Trial Screen Failures With no Obstructive CAD on Coronary CT Angiography

Changes in Ischemia and Angina Over One Year Among ISCHEMIA Trial Screen Failures

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02347215
Acronym
CIAO
Enrollment
212
Registered
2015-01-27
Start date
2014-08-31
Completion date
2019-12-31
Last updated
2020-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Angina Pectoris, Microvascular Angina

Brief 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.

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.

Interventions

OTHERQuality of Life assessment

Seattle Angina Questionnaire and other questionnaires.

PROCEDUREStress imaging

Stress imaging

Sponsors

Duke Clinical Research Institute
CollaboratorOTHER
Massachusetts General Hospital
CollaboratorOTHER
NYU Langone Health
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Inability to comply with protocol * Prior PCI or CABG

Design outcomes

Primary

MeasureTime frame
Seattle Angina Questionnaire (SAQ) scorebaseline-one year comparison

Secondary

MeasureTime frameDescription
Ischemia severitybaseline-one year comparison
Coronary atherosclerosis severity (comparison with SAQ score and with ischemia severity)baselinecomparison with SAQ score and with ischemia severity
Ischemia severity (comparison with SAQ score and with ischemia severity)baselinecomparison with SAQ score and with atherosclerosis severity
Medical therapy used for angina (comparison with SAQ score and ischemia severity)one yearcomparison with SAQ score and ischemia severity
Major adverse cardiac eventsone yeardeath, MI, stroke, cardiovascular hospitalizations/ER visits

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026