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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 in multi detector-row computed tomography angiography (MDCTA) evaluation has high diagnostic accuracy to evaluate coronary artery stenosis. However, previous report assessing imaging findings or diagnostic accuracy of MDCTA in patients with vasospastic angina (VSA) is lacking.
Previously investigators analyzed the characteristics of coronary spasm segment in an observational individual dataset, suspected VSA patients (n=20) underwent dual-acquisition of MDCTA (initial and intravenous nitrate injected CT imaging), the diagnostic accuracy showed sensitivity: 73%, specificity: 100%, positive predictive value: 100%, and negative predictive value: 56%.
Further study is necessary because previous analysis presented limited sample size and deficiency of healthy control.
Therefore, investigators hypothesis that dual-acquisition of MDCTA in noninvasive tool for coronary assessment provide more information of coronary characteristics, and the diagnostic efficacy would be non-inferior as compared with the invasive coronary imaging modality in coronary spasm-induced angina attacks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spasm positive | Experimental | Ergonovine-induced coronary spasm provocation test positive: defined as transient, total, or sub-total occlusion (>90% stenosis) of a coronary artery with symptoms of myocardial ischemia (angina pain and ischemic ECG change). |
|
| Spasm negative | Placebo Comparator | Suspected vasospastic angina subjects with negative ergonovine provocation test are considered as reference modality. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spasm positive | Diagnostic Test | Investigators define the positive criteria for VSA on MDCTA as follows:
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability | MDCTA procedure: all subjects will undergo MDCTA without a vasodilator ("initial CT") in the early morning before the ergonovine provocation spasm test. Subsequent "IV nitrate CT" will be allowed at a 3-day washout period after the first contrast usage. The scan protocol for the IV nitrate CT is as follows: during continuous injection of the intravenous vasodilating agent (isosorbidedinitrate 2 mg/hr), blood pressure will be checked every 2 minutes. When both the systolic and diastolic blood pressure decrease by 10 mmHg in comparison to the initial value, the CT scan initiate and images will be acquired during the nitrate infusion. Investigators define the positive criteria for VSA on MDCTA as follows:
| 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Coronary vessel distensibility | To evaluate the extent of coronary vessel distensibility by dual-acquisition of cardiac MDCTA in patients with VSA | 3 days |
| Cutoff value of coronary vessel distensibility index |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Moo Hyun Kim, MD | Contact | +82-51-240-2976 | kimmh@dau.ac.kr | |
| Cai De Jin, MD | Contact | +86-178-0250-2582 | jincaide1118@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Moo Hyun Kim, MD | Dong-A University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dong-A University Hospital | Recruiting | Busan | 602-715 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27380904 | Background | Kang EJ, Kim MH, De Jin C, Seo J, Kim DW, Yoon SK, Park TH, Lee KN, Choi SI, Yoon YE. Noninvasive detection of coronary vasospastic angina using a double-acquisition coronary CT angiography protocol in the presence and absence of an intravenous nitrate: a pilot study. Eur Radiol. 2017 Mar;27(3):1136-1147. doi: 10.1007/s00330-016-4476-2. Epub 2016 Jul 6. | |
| 29166637 |
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| ID | Term |
|---|---|
| D013035 | Spasm |
| D003329 | Coronary Vasospasm |
| ID | Term |
|---|---|
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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|
| Spasm negative | Diagnostic Test | Suspected vasospastic angina subjects with negative MDCTA-derived VSA are considered as reference modality. |
|
To consider the cutoff value of coronary vessel distensibility index (CVDI) to predict the coronary spasm induced angina-like attacks.
Investigators define the CVDI as following formulas:
| 3 days |
| Incidence of multi-vessel spasm | To examine the incidence of multi-vessel coronary spasm by MDCTA. | 3 days |
| Diagnostic accuracy of MDCTA | To determine the diagnostic accuracy of MDCTA modalities for detection of VSA. | 3 days |
| Characteristics of spasm-related coronary artery segment | To describe the characteristics of spasm-related coronary artery segment including vessel remodeling, plaque composition and stenosis degree. | 3 days |
| Jin C, Kim MH, Kang EJ, Cho YR, Park TH, Lee KN, Serebruany V. Assessing Vessel Tone during Coronary Artery Spasm by Dual-Acquisition Multidetector Computed Tomography Angiography. Cardiology. 2018;139(1):25-32. doi: 10.1159/000478926. Epub 2017 Nov 23. |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |