A Comparative Study of Different Treadmill Scores to Diagnose Coronary Artery Disease

NCT02879032 | Completed Results DMC

• 1 other identifier: MAlam-01
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

Exercise treadmill test (ETT) is frequently done, inexpensive, relatively safe investigation for diagnosis of ischemic heart disease and prediction of exercise capacity. Ischemic heart disease is increasing by leaps and bounds all over the world even in the developing countries like Bangladesh. The incidence rate of coronary artery disease (CAD) is not limited to male gender as previously seen. As a cause of industrialization and increased life expectancy, incidence of ischemic heart disease in females is escalating now in Bangladesh also. Though ETT is a well accepted investigation to diagnose CAD, it has a high false positive and false negative result if ST segment response alone is calculated for interpretation of the test. Duke Treadmill Test and Simple Treadmill Test are valid and well known scores which can predict coronary artery disease burden more efficiently than ST segment response alone. Computer generated Cleveland clinic score is another valid treadmill score which has a complex algorithm but effective way to predict 3 year and 5 year survivability. These three scores are well tested on western population but to our best knowledge there is little or no information regarding their predictability of CAD in Bangladesh. It's well known that ETT has a high false positive result in female population, so applying the scores may render ETT more efficient and abrogate unwanted risk of undergoing coronary angiography to diagnose CAD in females. In this study the investigator will try to find out the accuracy of commonly applied treadmill scores and ST segment response to diagnose CAD as well as accuracy of computer generated Cleveland Clinic Score will be tested. Total 110 people including male and female will be included according to inclusion and exclusion criteria and informed written consent will be taken. The patients who have undergone ETT and coronary angiogram with in six months for confirmation and identification of coronary artery disease in accordance with the recommendation of ACC guideline for CAG will be selected . All available data will be analyzed using SPSS. The accuracy of different scores will be calculated and compared with each other. According to currently available data from studies in western population the treadmill scores will have good predictability and will be efficient to abolish high false positive result in female population in Bangladesh.

Conditions

Stable Ischemic Heart Disease

Keywords

Treadmill Scores; Coronary Angiogram; Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Exercise Treadmill Scores

  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).

  12 months

Eligibility Criteria

• Age: 30 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All stable patients visited University Cardiac Center, Bangabandhu Sheikh Mujib Medical University (BSMMU) for evaluation of stable chest pain.

You may qualify if:

• Patients undergone CAG and ETT within 6 months interval for stable ischemic heart disease.
• Age between 30-69 years

You may not qualify if:

• Any contraindication for Exercise Tolerance test
• Previous myocardial infarction by history or ECG
• Previous revascularization or valvular heart disease
• Baseline abnormalities that may obscure electrocardiographic changes during exercise

Sponsors & Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: lead

Study Sites (1)

Bangabandhu Sheikh Mujib Medical University

Dhaka, 1000, Bangladesh

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Results Point of Contact

• Title: Dr. Md. Mashiul Alam
• Organization: Bangabandhu Sheikh Mujib Medical University

mashiull@gmail.com

+8801724490475

Study Officials

• Md. Mashiul Alam, MBBS

  Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident, University Cardiac Center

Study Record Dates

• First Submitted: August 12, 2016
• First Posted: August 25, 2016
• Study Start: July 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: October 24, 2019
• Results First Posted: October 24, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Always available on request sent to our email
• Access Criteria: Open for all physicians who want data for study

Locations

BA (1)