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Table 2 Inclusion and exclusion criteria

From: Understanding of chest pain in microvascular disease proved by cardiac magnetic resonance image (UMPIRE): study protocol for a randomized controlled trial

Inclusion criteria

 

1

MVA patients with typical symptom and positive adenosine-stress CMR and with normal coronary artery in CCTA or coronary angiography.

2

Definition of positive adenosine-stress CMR: perfusion defect >25% of transmurality (by two radiologists based on visual assessment and qualitative assessment in core-lab)

3

Gender: female

4

Age: 18 to 80-years-old

Exclusion criteria

 

1

Patient has a contraindication to CMR contrast media or CMR imaging

2

LVEF <50%

3

Any heart rhythm abnormality other than sinus rhythm

4

Valvular heart disease with more than moderate degree

5

Renal failure

6

Congestive heart failure

7

Myocardial infraction

8

Myocarditis

9

Congenital heart disease

10

Pericarditis

11

Variant angina (positive provocation test with ergonovine or acetylcholine)

12

GERD (conformed by esophagogastroduodenoscopy)

13

Pregnant women, suspected pregnant women or lactating women

14

QT prolongation syndrome or taking drugs that prolong the QT interval:

 

- Antiarrhythmics class IA; quinidine, procainamide

 

- Antiarrhythmics class III; amiodarone, sotalol

15

Pre-analytical within 30 days of screening in a clinical trial that may affect the influence of udenafil:

 

- Other PDE-5 inhibitors (for example sildenafil, tadalafil)

 

- Nitrates/NO donor (for example nitroglycerin, isosorbide mononitrate, isosorbide dinitrate, amyl nitrate/nitrite, sodium nitroprusside, and nicorandil)

16

Pre-analytical within seven days of screening in a clinical trial that may affect the metabolism of udenafil:

 

- Antibacterials (for example erythromycin)

 

- Antifungals (for example itraconazole, ketoconazole)

 

- Antivirals (for example ritonavir, saquinavir, amprenavir, indinavir, nelfinavir)

 

- Cimetidine

 

- Grapefruit juice

17

Allergy or sensitivity with PDE-5 inhibitors

  1. CCTA; Coronary CT angiography, CMR; Cardiac magnetic resonance image, GERD; Gastroesophageal reflux disorder, LVEF; Left ventricular ejection fraction, MVA; Microvascular angina, NO; Nitric oxide, PDE-5; Phosphodiesterase-5.