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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 (CIAO)

Primary Purpose

Microvascular Angina, Angina Pectoris

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Quality of Life assessment
Stress imaging
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Microvascular Angina

Eligibility Criteria

21 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NYU Medical Center and Bellevue Hospital Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

All patients

Arm Description

All patients undergo quality of life assessment at 2-3 time points and stress imaging at two time points

Outcomes

Primary Outcome Measures

Seattle Angina Questionnaire (SAQ) score

Secondary Outcome Measures

Ischemia severity
Coronary atherosclerosis severity (comparison with SAQ score and with ischemia severity)
comparison with SAQ score and with ischemia severity
Ischemia severity (comparison with SAQ score and with ischemia severity)
comparison with SAQ score and with atherosclerosis severity
Medical therapy used for angina (comparison with SAQ score and ischemia severity)
comparison with SAQ score and ischemia severity
Major adverse cardiac events
death, MI, stroke, cardiovascular hospitalizations/ER visits

Full Information

First Posted
January 14, 2015
Last Updated
February 13, 2020
Sponsor
NYU Langone Health
Collaborators
Duke Clinical Research Institute, Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02347215
Brief Title
Changes in Ischemia and Angina Over 1 Year Among ISCHEMIA Trial Screen Failures With no Obstructive CAD on Coronary CT Angiography
Acronym
CIAO
Official Title
Changes in Ischemia and Angina Over One Year Among ISCHEMIA Trial Screen Failures
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
August 2014 (Actual)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
December 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
Duke Clinical Research Institute, Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Microvascular Angina, Angina Pectoris

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
212 (Actual)

8. Arms, Groups, and Interventions

Arm Title
All patients
Arm Type
Other
Arm Description
All patients undergo quality of life assessment at 2-3 time points and stress imaging at two time points
Intervention Type
Other
Intervention Name(s)
Quality of Life assessment
Intervention Description
Seattle Angina Questionnaire and other questionnaires.
Intervention Type
Procedure
Intervention Name(s)
Stress imaging
Intervention Description
Stress imaging
Primary Outcome Measure Information:
Title
Seattle Angina Questionnaire (SAQ) score
Time Frame
baseline-one year comparison
Secondary Outcome Measure Information:
Title
Ischemia severity
Time Frame
baseline-one year comparison
Title
Coronary atherosclerosis severity (comparison with SAQ score and with ischemia severity)
Description
comparison with SAQ score and with ischemia severity
Time Frame
baseline
Title
Ischemia severity (comparison with SAQ score and with ischemia severity)
Description
comparison with SAQ score and with atherosclerosis severity
Time Frame
baseline
Title
Medical therapy used for angina (comparison with SAQ score and ischemia severity)
Description
comparison with SAQ score and ischemia severity
Time Frame
one year
Title
Major adverse cardiac events
Description
death, MI, stroke, cardiovascular hospitalizations/ER visits
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith Hochman, MD
Organizational Affiliation
New York Langone Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Medical Center and Bellevue Hospital Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34058845
Citation
Reynolds 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.
Results Reference
derived

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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

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