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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)

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ClinicalTrials.gov Identifier: NCT02347215
Recruitment Status : Active, not recruiting
First Posted : January 27, 2015
Last Update Posted : April 22, 2019
Sponsor:
Collaborators:
Duke Clinical Research Institute
Massachusetts General Hospital
Information provided by (Responsible Party):
New York University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Microvascular Angina Angina Pectoris Other: Quality of Life assessment Procedure: Stress imaging Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 212 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Changes in Ischemia and Angina Over One Year Among ISCHEMIA Trial Screen Failures
Actual Study Start Date : August 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina

Arm Intervention/treatment
All patients
All patients undergo quality of life assessment at 2-3 time points and stress imaging at two time points
Other: Quality of Life assessment
Seattle Angina Questionnaire and other questionnaires.

Procedure: Stress imaging
Stress imaging




Primary Outcome Measures :
  1. Seattle Angina Questionnaire (SAQ) score [ Time Frame: baseline-one year comparison ]

Secondary Outcome Measures :
  1. Ischemia severity [ Time Frame: baseline-one year comparison ]
  2. Coronary atherosclerosis severity (comparison with SAQ score and with ischemia severity) [ Time Frame: baseline ]
    comparison with SAQ score and with ischemia severity

  3. Ischemia severity (comparison with SAQ score and with ischemia severity) [ Time Frame: baseline ]
    comparison with SAQ score and with atherosclerosis severity

  4. Medical therapy used for angina (comparison with SAQ score and ischemia severity) [ Time Frame: one year ]
    comparison with SAQ score and ischemia severity

  5. Major adverse cardiac events [ Time Frame: one year ]
    death, MI, stroke, cardiovascular hospitalizations/ER visits



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02347215


Locations
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United States, New York
NYU Medical Center and Bellevue Hospital Center
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Duke Clinical Research Institute
Massachusetts General Hospital
Investigators
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Principal Investigator: Judith Hochman, MD New York Langone Medical Center

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Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT02347215     History of Changes
Other Study ID Numbers: s11-00498
First Posted: January 27, 2015    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Ischemia
Angina Pectoris
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms