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Multidetector Coronary CT In Vasospastic Angina

Primary Purpose

Vasospastic Angina

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Positive CAG with EG test
Negative CAG with EG test
Sponsored by
Dong-A University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Vasospastic Angina focused on measuring Multi-detector computed tomography angiography, Coronary vessel distensibility, Coronary spasm

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Onset of angina-like attack at rest, during effort, or during rest and effort.
  • Patients will be scheduled to undergo multi-detector computed tomography angiography and coronary angiography with an ergonovine provocation test.

Exclusion Criteria:

  • Evidence of acute coronary syndrome, cardiomyopathy and valvular heart disease.
  • More than 50% stenosis detected by coronary angiography .
  • Renal insufficiency (serum creatine>2.5 mg/dl).

Sites / Locations

  • DongA University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Positive CAG with EG test

Negative CAG with EG test

Arm Description

A positive finding for coronary angiography with an ergonovine provocation test is defined as transient, total, or sub-total occlusion (>90% stenosis) with signs/symptoms of myocardial ischemia (chest pain and ischemic ECG change).

Negative test: less than 70% luminal narrowing, without chest pain or ST-segment changes after ergonovine coronary injection

Outcomes

Primary Outcome Measures

Characteristics of coronary lesion
Plaque composition: noncalcified plaque, which is < 130 Hounsfield units(HU). Calcified plaque with a density of > 130 HU. Mixed plaque: plaque area consisted of > 50% of non-calcified plaque. The remodeling index (RI) was calculated by dividing the cross-sectional lesion vessel-area by the reference vessel area.Positive remodeling was defined as RI > 1.05, otherwise RI ≤0.95. Significant stenosis is defined as stenosis in more than 50% of the coronary artery diameter.

Secondary Outcome Measures

Full Information

First Posted
June 29, 2014
Last Updated
July 21, 2020
Sponsor
Dong-A University
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1. Study Identification

Unique Protocol Identification Number
NCT02180971
Brief Title
Multidetector Coronary CT In Vasospastic Angina
Official Title
Diagnostic Usefulness of Multidetector Coronary CT in Vasospastic Angina
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (undefined)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
March 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dong-A University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to compare the extent of coronary vessel stenosis between coronary spasm-induced angina attacks (named vasospastic angina, VSA) patients and health volunteers by multi-detector computed tomography angiography (MDCTA), and to evaluate the diagnostic efficacy of MDCTA in patients with VSA.
Detailed Description
Vasospastic angina (VSA) was characterized by transient ischemic ST-segment change during angina attacks. Coronary spasm provocation test, as a diagnostic golden standard, has been widely used for the management of VSA according to JCS 2013 guidelines. With regard to the characteristics of spasm segment, had been clearly described by other invasive imaging methods including intravascular ultrasound and optical coherence tomography. However, there is potential risk during these invasive procedures, such as severe myocardial ischemia or fatal arrhythmia. Presently available imaging test for coronary artery disease including multi-detector computed tomography angiography (MDCTA) with high diagnostic accuracy to evaluate coronary artery stenosis. However, the diagnostic accuracy of MDCTA in patients with VSA is lacking. Therefore, more efficient and safe noninvasive diagnostic method is required for the detection of angina-like attacks patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vasospastic Angina
Keywords
Multi-detector computed tomography angiography, Coronary vessel distensibility, Coronary spasm

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Positive CAG with EG test
Arm Type
Experimental
Arm Description
A positive finding for coronary angiography with an ergonovine provocation test is defined as transient, total, or sub-total occlusion (>90% stenosis) with signs/symptoms of myocardial ischemia (chest pain and ischemic ECG change).
Arm Title
Negative CAG with EG test
Arm Type
Experimental
Arm Description
Negative test: less than 70% luminal narrowing, without chest pain or ST-segment changes after ergonovine coronary injection
Intervention Type
Procedure
Intervention Name(s)
Positive CAG with EG test
Intervention Description
A positive finding for coronary angiography with an ergonovine provocation test is defined as transient, total, or sub-total occlusion (>90% stenosis) with signs/symptoms of myocardial ischemia (chest pain and ischemic ECG change).
Intervention Type
Procedure
Intervention Name(s)
Negative CAG with EG test
Intervention Description
Negative test: less than 70% luminal narrowing, without chest pain or ST-segment changes after ergonovine coronary injection
Primary Outcome Measure Information:
Title
Characteristics of coronary lesion
Description
Plaque composition: noncalcified plaque, which is < 130 Hounsfield units(HU). Calcified plaque with a density of > 130 HU. Mixed plaque: plaque area consisted of > 50% of non-calcified plaque. The remodeling index (RI) was calculated by dividing the cross-sectional lesion vessel-area by the reference vessel area.Positive remodeling was defined as RI > 1.05, otherwise RI ≤0.95. Significant stenosis is defined as stenosis in more than 50% of the coronary artery diameter.
Time Frame
CAG will be performed after multidetector coronary CT, an expected average of 4 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Onset of angina-like attack at rest, during effort, or during rest and effort. Patients will be scheduled to undergo multi-detector computed tomography angiography and coronary angiography with an ergonovine provocation test. Exclusion Criteria: Evidence of acute coronary syndrome, cardiomyopathy and valvular heart disease. More than 50% stenosis detected by coronary angiography . Renal insufficiency (serum creatine>2.5 mg/dl).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Moo Hyun Kim, M.D.
Phone
+82-51-240-2976
Email
kimmh@dau.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moo Hyun Kim, M.D.
Organizational Affiliation
Dong-A University Hospital, Busan, Republic of Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
DongA University Hospital
City
Busan
ZIP/Postal Code
602-715
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Moo Hyun Kim, M.D.
Phone
+82-51-240-2976
Email
kimmh@dau.ac.kr

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
22247633
Citation
Kang KM, Choi SI, Chun EJ, Kim JA, Youn TJ, Choi DJ. Coronary vasospastic angina: assessment by multidetector CT coronary angiography. Korean J Radiol. 2012 Jan-Feb;13(1):27-33. doi: 10.3348/kjr.2012.13.1.27. Epub 2011 Dec 23.
Results Reference
result
PubMed Identifier
16357399
Citation
Ghersin E, Litmanovich D, Dragu R, Rispler S, Lessick J, Ofer A, Brook OR, Gruberg L, Beyar R, Engel A. 16-MDCT coronary angiography versus invasive coronary angiography in acute chest pain syndrome: a blinded prospective study. AJR Am J Roentgenol. 2006 Jan;186(1):177-84. doi: 10.2214/AJR.04.1232.
Results Reference
result
PubMed Identifier
25273915
Citation
JCS Joint Working Group. Guidelines for diagnosis and treatment of patients with vasospastic angina (Coronary Spastic Angina) (JCS 2013). Circ J. 2014;78(11):2779-801. doi: 10.1253/circj.cj-66-0098. Epub 2014 Sep 30. No abstract available.
Results Reference
result
PubMed Identifier
23453453
Citation
Tsujita K, Sakamoto K, Kojima S, Kojima S, Takaoka N, Nagayoshi Y, Sakamoto T, Tayama S, Kaikita K, Hokimoto S, Sumida H, Sugiyama S, Nakamura S, Ogawa H. Coronary plaque component in patients with vasospastic angina: a virtual histology intravascular ultrasound study. Int J Cardiol. 2013 Oct 3;168(3):2411-5. doi: 10.1016/j.ijcard.2013.02.002. Epub 2013 Feb 27.
Results Reference
result
PubMed Identifier
19716193
Citation
Morikawa Y, Uemura S, Ishigami K, Soeda T, Okayama S, Takemoto Y, Onoue K, Somekawa S, Nishida T, Takeda Y, Kawata H, Horii M, Saito Y. Morphological features of coronary arteries in patients with coronary spastic angina: assessment with intracoronary optical coherence tomography. Int J Cardiol. 2011 Feb 3;146(3):334-40. doi: 10.1016/j.ijcard.2009.07.011. Epub 2009 Aug 27.
Results Reference
result

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Multidetector Coronary CT In Vasospastic Angina

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