Are you healthy and looking to help advance medical science?

You may be eligible to participate in a vasospastic angina clinical study, and could be compensated for your time.

Are you healthy and looking to help advance medical science? You may be eligible to participate in a vasospastic angina clinical study, and could be compensated for your time.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Vasospastic Angina Clinical Trial in Busan

NCT02180971 | Interventional

Are you healthy and looking to help advance medical science?

You may be eligible to participate in a vasospastic angina clinical study, and could be compensated for your time.

Are you healthy and looking to help advance medical science? You may be eligible to participate in a vasospastic angina clinical study, and could be compensated for your time.

Recruiting

Male & Female

20 - 80

Years old

This study is looking to recruit 150 Participants

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.

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Details for the study

Brief Title

Multidetector Coronary CT In Vasospastic Angina

Official Title

Diagnostic Usefulness of Multidetector Coronary CT in Vasospastic Angina

Brief Summary

The purpose of this study is to compare the extent of coronary vessel stenosis between<br /> coronary spasm-induced angina attacks (named vasospastic angina, VSA) patients and health<br /> volunteers by multi-detector computed tomography angiography (MDCTA), and to evaluate the<br /> 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.

Treatments and/or Procedures

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).

Negative CAG with EG test

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

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

Primary

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.

CAG will be performed after multidetector coronary CT, an expected average of 4 weeks.

Study 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).