NCT02347215

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
212

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 27, 2015

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

February 17, 2020

Status Verified

February 1, 2020

Enrollment Period

5.3 years

First QC Date

January 14, 2015

Last Update Submit

February 13, 2020

Conditions

Microvascular AnginaAngina Pectoris

Outcome Measures

Primary Outcomes (1)

  • Seattle Angina Questionnaire (SAQ) score

    baseline-one year comparison

Secondary Outcomes (5)

  • Ischemia severity

    baseline-one year comparison

  • Coronary atherosclerosis severity (comparison with SAQ score and with ischemia severity)

    baseline

  • Ischemia severity (comparison with SAQ score and with ischemia severity)

    baseline

  • Medical therapy used for angina (comparison with SAQ score and ischemia severity)

    one year

  • Major adverse cardiac events

    one year

Study Arms (1)

All patients

OTHER

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

Other: Quality of Life assessmentProcedure: Stress imaging

Interventions

Quality of Life assessmentOTHER

Seattle Angina Questionnaire and other questionnaires.

All patients
Stress imagingPROCEDURE

Stress imaging

All patients

Eligibility Criteria

Age21 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Inability to comply with protocol
  • Prior PCI or CABG

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Medical Center and Bellevue Hospital Center

New York, New York, 10016, United States

Location

Related Publications (2)

  • 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.

    PMID: 39996455DERIVED

  • 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.

    PMID: 34058845DERIVED

MeSH Terms

Conditions

Microvascular AnginaAngina Pectoris

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Judith Hochman, MD

    New York Langone Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2015

First Posted

January 27, 2015

Study Start

August 1, 2014

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

February 17, 2020

Record last verified: 2020-02

Locations

US(1)