Trial Outcomes & Findings for Correlational Study on the Biomarkers Application to the Prediction and Diagnosis of Cardiovascular Diseases (NCT NCT02179047)

Results Overview

The titer of 6 biomarkers(NGAL,Cystatin C,Galectin-3,Copeptin,MR-Pro ANP,sST2).

Recruitment status

COMPLETED

Target enrollment

214 participants

Primary outcome timeframe

6-12 months

Results posted on

2020-02-25

Participant Flow

Participant milestones

Participant milestones
Measure	Intervention patients with stable angina who received coronary angiography and percutaneous coronary intervention.	Placebo healthy subjects
Overall Study STARTED	194	20
Overall Study COMPLETED	187	20
Overall Study NOT COMPLETED	7	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Correlational Study on the Biomarkers Application to the Prediction and Diagnosis of Cardiovascular Diseases

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stable Angina n=187 Participants receive coronary angiogram	Placebo n=20 Participants healthy subjects	Total n=207 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	137 Participants n=5 Participants	14 Participants n=7 Participants	151 Participants n=5 Participants
Age, Categorical >=65 years	50 Participants n=5 Participants	6 Participants n=7 Participants	56 Participants n=5 Participants
Age, Continuous	62 years STANDARD_DEVIATION 14 • n=5 Participants	60 years STANDARD_DEVIATION 12 • n=7 Participants	61 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	50 Participants n=5 Participants	6 Participants n=7 Participants	56 Participants n=5 Participants
Sex: Female, Male Male	137 Participants n=5 Participants	14 Participants n=7 Participants	151 Participants n=5 Participants
Region of Enrollment Taiwan	187 participants n=5 Participants	20 participants n=7 Participants	207 participants n=5 Participants

PRIMARY outcome

Timeframe: 6-12 months

The titer of 6 biomarkers(NGAL,Cystatin C,Galectin-3,Copeptin,MR-Pro ANP,sST2).

Outcome measures

Outcome measures
Measure	NGAL n=187 lesions biomarker	Cystatin C n=187 lesions biomarker	Galectin-3 n=187 lesions biomarker	Copeptin n=187 lesions biomarker	MR-Pro ANP n=187 lesions biomarker	sST2 n=187 lesions biomarker	Placebo(Healthy Subjects) patients without stable angina who received coronary angiography.
Biomarker Titer of Patients With Coronary Artery Disease	13 tilter Interval 2.0 to 36.0	5 tilter Interval 0.0 to 10.0	60 tilter Interval 1.0 to 120.0	0.5 tilter Interval 0.024 to 0.76	0.16 tilter Interval 0.008 to 0.26	184 tilter Interval 9.0 to 218.0	—

PRIMARY outcome

Timeframe: 6-12 months

The relationship of 6 biomarkers(NGAL,Cystatin C,Galectin-3,Copeptin,MR-Pro ANP,sST2) of healthy subjects(placebo).

Outcome measures

Outcome measures
Measure	NGAL n=20 lesions biomarker	Cystatin C n=20 lesions biomarker	Galectin-3 n=20 lesions biomarker	Copeptin n=20 lesions biomarker	MR-Pro ANP n=20 lesions biomarker	sST2 n=20 lesions biomarker	Placebo(Healthy Subjects) patients without stable angina who received coronary angiography.
Biomarker of Healthy Subjects(Placebo)	12 tilter Interval 1.0 to 34.0	4 tilter Interval 1.0 to 12.0	52 tilter Interval 2.0 to 82.0	0.1 tilter Interval 0.01 to 0.4	0.12 tilter Interval 0.09 to 0.83	121 tilter Interval 68.0 to 178.0	—

PRIMARY outcome

Timeframe: 6-12 months

Population: The SYNTAX Score is a unique tool to score complexity of coronary artery disease; there is no theoretical range existed for the SYNTAX score. SYNTAX Web site: http://www.syntaxscore.com/index.php Low risk:\<22; intermediate risk: 22-33, high risk:\>33

The relationship of 6 biomarkers(NGAL,Cystatin C,Galectin-3,Copeptin,MR-Pro ANP,sST2) with SYNTAX score. The SYNTAX Score is a unique tool to score complexity of coronary artery disease; there is no theoretical range existed for the SYNTAX score. Low risk:\<22; intermediate risk: 22-33, high risk:\>33

Outcome measures

Outcome measures
Measure	NGAL n=187 lesions biomarker	Cystatin C n=187 lesions biomarker	Galectin-3 n=187 lesions biomarker	Copeptin n=187 lesions biomarker	MR-Pro ANP n=187 lesions biomarker	sST2 n=187 lesions biomarker	Placebo(Healthy Subjects) n=187 lesions patients without stable angina who received coronary angiography.
SYNTAX(SYNergy Between Percutaneous Coronary Intervention With TAXus) for Stable Angina Receveived Coronary Angiogram	22 scores on a scale Standard Deviation 8	19 scores on a scale Standard Deviation 4	32 scores on a scale Standard Deviation 8	28 scores on a scale Standard Deviation 13	33 scores on a scale Standard Deviation 15	19 scores on a scale Standard Deviation 3	6 scores on a scale Standard Deviation 2

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

chen yueh-chung

taipei city hospital

Phone: 88627093600

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place