Trial Outcomes & Findings for A Comparative Study of Different Treadmill Scores to Diagnose Coronary Artery Disease (NCT NCT02879032)

Last Updated: 2019-10-24

Results Overview

Using angiographic evidence of Coronary Artery Disease (CAD) as the reference, area under the curve (AUC) of Receiver operating characteristic (ROC) plots were determined for each treadmill score. The AUC for each treadmill score was compared the AUCs of the other treadmill scores. Maximum value for AUC is 1 where value towards 1 means more accurate treadmill score. Based on the study by Shaw et al. (1998), DTS \<+5 is considered abnormal. High risk when DTS is \<-10 and low risk when DTS is \>+5. The simplified score had a rang from 6 to 95, with \<40 designated as low probability, between 40-60 was intermediate probability, and \>60 was high probability for CAD. STS calculation for male and female subjects was done by formula provided by Raxwal et al. (2002) and Morise et al. (2002), respectively. Arbitrarity we have assumed CCS will predict significant CAD with high probability if the value is \>100 and low probability if it is \<80 (Lauer et al. 2007).

Recruitment status

COMPLETED

Target enrollment

130 participants

Primary outcome timeframe

12 months

Results posted on

2019-10-24

Participant Flow

Patient presented with stable chest pain who have undergone ETT according to Bruce protocol were selected as case considering inclusion and exclusion criteria.Cases other than stable chest pain were excluded. Informed written consent was taken from the patient. CAG report was collected from the Cath lab after the procedure.

Participant milestones

Participant milestones
Measure	Patients With Stable Angina All patients visited University Cardiac Center, Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka for evaluation of stable chest pain were included according to following inclusion and exclusion criteria. Inclusion criteria: 1. Male and female patients undergone ETT and CAG within 6 months interval for stable angina. (Fearon et al. 2002) 2. Age between 30-69 years (Gibbons et al. 2002) Exclusion criteria: 1. Previous myocardial infarction by history or ECG 2. Previous revascularization or valvular heart disease 3. Baseline abnormalities that may obscure electrocardiographic changes during exercise * Left bundle branch block or Right bundle branch block * Left ventricular hypertrophy with repolarization abnormality * Digitalis therapy * Vantricular paced rhythm * Wolf-Perkinson-White syndrome * ST abnormality associated with supraventricular tachycardia or atrial fibrillation
Overall Study STARTED	130
Overall Study COMPLETED	130
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients With Stable Angina n=130 Participants All patients visited University Cardiac Center, Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka for evaluation of stable chest pain were included according to following inclusion and exclusion criteria. Inclusion criteria: 1. Male and female patients undergone ETT and CAG within 6 months interval for stable angina. (Fearon et al. 2002) 2. Age between 30-69 years (Gibbons et al. 2002) Exclusion criteria: 1. Previous myocardial infarction by history or ECG 2. Previous revascularization or valvular heart disease 3. Baseline abnormalities that may obscure electrocardiographic changes during exercise * Left bundle branch block or Right bundle branch block * Left ventricular hypertrophy with repolarization abnormality * Digitalis therapy * Vantricular paced rhythm * Wolf-Perkinson-White syndrome * ST abnormality associated with supraventricular tachycardia or atrial fibrillation
Age, Categorical <=18 years	0 Participants n=130 Participants
Age, Categorical Between 18 and 65 years	119 Participants n=130 Participants
Age, Categorical >=65 years	11 Participants n=130 Participants
Age, Continuous	50 years STANDARD_DEVIATION 9 • n=130 Participants
Sex: Female, Male Female	37 Participants n=130 Participants
Sex: Female, Male Male	93 Participants n=130 Participants
Region of Enrollment Bangladesh	130 participants n=130 Participants
Patients age were between 30-69 years	130 participants n=130 Participants

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	Duke Treadmill Score n=130 Participants Based on the study by Shaw et al. (1998), DTS \<+5 is considered abnormal. High risk when DTS is \<-10 and low risk when DTS is \>+5.	Simple Treadmill Score n=130 Participants The simplified score had a rang from 6 to 95, with \<40 designated as low probability, between 40-60 was intermediate probability, and \>60 was high probability for CAD. STS calculation for male and female subjects was done by formula provided by Raxwal et al. (2002) and Morise et al. (2002), respectively	Cleveland Clinic Score n=130 Participants we have assumed CCS will predict significant CAD with high probability if the value is \>100 and low probability if it is \<80 (Lauer et al. 2007)
Exercise Treadmill Scores	0.771 Probability by AUC Interval 0.68 to 0.84	0.772 Probability by AUC Interval 0.69 to 0.84	0.768 Probability by AUC Interval 0.68 to 0.83

Adverse Events

Patients With Stable Angina

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Md. Mashiul Alam

Bangabandhu Sheikh Mujib Medical University

Phone: +8801724490475

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place