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Multidetector Coronary CT In Vasospastic Angina

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ClinicalTrials.gov Identifier: NCT02180971
Recruitment Status : Recruiting
First Posted : July 3, 2014
Last Update Posted : February 11, 2019
Sponsor:
Information provided by (Responsible Party):
Moo Hyun Kim, Dong-A University

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.

Condition or disease Intervention/treatment Phase
Vasospastic Angina Procedure: Positive CAG with EG test Procedure: Negative CAG with EG test Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Diagnostic Usefulness of Multidetector Coronary CT in Vasospastic Angina
Study Start Date : April 2014
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina

Arm Intervention/treatment
Experimental: Positive CAG with EG test
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).
Procedure: Positive CAG with EG test
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).

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




Primary Outcome Measures :
  1. Characteristics of coronary lesion [ Time Frame: CAG will be performed after multidetector coronary CT, an expected average of 4 weeks. ]
    1. 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.
    2. 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.
    3. Significant stenosis is defined as stenosis in more than 50% of the coronary artery diameter.



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

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): NCT02180971


Contacts
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Contact: Moo Hyun Kim, M.D. +82-51-240-2976 kimmh@dau.ac.kr

Locations
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Korea, Republic of
DongA University Hospital Recruiting
Busan, Korea, Republic of, 602-715
Contact: Moo Hyun Kim, M.D.    +82-51-240-2976    kimmh@dau.ac.kr   
Sponsors and Collaborators
Dong-A University
Investigators
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Principal Investigator: Moo Hyun Kim, M.D. Dong-A University Hospital, Busan, Republic of Korea

Publications of Results:
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Responsible Party: Moo Hyun Kim, M.D. Director, Regional Clinical Trial Center. Professor, Dept. of Cardiology Dong-A Unicersity Hospital, Dong-A University
ClinicalTrials.gov Identifier: NCT02180971     History of Changes
Other Study ID Numbers: DOMINATION
First Posted: July 3, 2014    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Moo Hyun Kim, Dong-A University:
Multi-detector computed tomography angiography
Coronary vessel distensibility
Coronary spasm

Additional relevant MeSH terms:
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Angina Pectoris
Angina Pectoris, Variant
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Angina, Unstable
Ergonovine
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs