Trial Outcomes & Findings for Early Risk Stratification in ED Chest Pain Patients (NCT NCT02364271)

NCT ID: NCT02364271

Last Updated: 2021-04-15

Results Overview

The primary outcome is the number of patients with MACE within 30 days after initial ED presentation. MACE is defined as relating to safety outcome, or effecacy outcome.

• Recruitment status: COMPLETED
• Target enrollment: 602 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2021-04-15

Participant Flow

Participant milestones

Measure	Not Low Risk Group Routine blood test for hs-cTnT, Thrombolysis in myocardial infarction score (TIMI) and mHEART score were performed on study patients. TIMI\>0 and mHEART\>2	Low Risk Group Routine blood test for hs-cTnT, Thrombolysis in myocardial infarction score (TIMI) and mHEART score were performed on study patients. TIMI=0 or mHEART\<=2
Overall Study STARTED	479	123
Overall Study COMPLETED	479	123
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Early Risk Stratification in ED Chest Pain Patients

Baseline characteristics by cohort

Measure	High Risk Group n=479 Participants Routine blood test for hs-cTnT, Thrombolysis in myocardial infarction score (TIMI) and mHEART score were performed on study patients. TIMI\>0 and mHEART\>2	Low Risk Group n=123 Participants Routine blood test for hs-cTnT, Thrombolysis in myocardial infarction score (TIMI) and mHEART score were performed on study patients. TIMI=0 or mHEART\<=2	Total n=602 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	165 Participants n=5 Participants	116 Participants n=7 Participants	281 Participants n=5 Participants
Age, Categorical >=65 years	314 Participants n=5 Participants	7 Participants n=7 Participants	321 Participants n=5 Participants
Age, Continuous	66.5 years n=5 Participants	66 years n=7 Participants	66 years n=5 Participants
Sex: Female, Male Female	241 Participants n=5 Participants	67 Participants n=7 Participants	308 Participants n=5 Participants
Sex: Female, Male Male	238 Participants n=5 Participants	56 Participants n=7 Participants	294 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	479 Participants n=5 Participants	123 Participants n=7 Participants	602 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment China	42 participants n=5 Participants	560 participants n=7 Participants	602 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Population: This is not an interventional trial. This prospective observational study to assess the efficiency of combining TIMI and HEART score in early exclusion of major adverse cardiac events in emergency department patients with chest pain

The primary outcome is the number of patients with MACE within 30 days after initial ED presentation. MACE is defined as relating to safety outcome, or effecacy outcome.

Outcome measures

Measure	Not Low Risk Groups n=479 Participants Patients with modified TIMI\>0 and modified HEART\>2 were considered as high risk for 30-day MACE. Modified TIMI and HEART scores included hs-cTnT tests as opposed to conventional cTnT in the original tests. The presence of any ST-deviation of \>0.05mV in the initial ECG was considered a positive result. A negative hs-cTnT result was defined as a concentration of ≤14ng/L.	Low Risk Group n=123 Participants Patients with modified TIMI=0 or modified HEART\<=2 were considered as low risk for 30-day MACE. Modified TIMI and HEART scores included hs-cTnT tests as opposed to conventional cTnT in the original tests. The presence of any ST-deviation of \>0.05mV in the initial ECG was considered a positive result. A negative hs-cTnT result was defined as a concentration of ≤14ng/L.
Number of Patients With Major Adverse Cardiac Event MACE within 30 days	42 Participants	0 Participants
Number of Patients With Major Adverse Cardiac Event No MACE within 30 days	437 Participants	123 Participants

SECONDARY outcome

Timeframe: 30 Days

Population: Patients with major adverse cardiac events occurred within 30-days

Outcome is the number of patients with safety MACE within 30 days after initial ED presentation. Safety MACE is defined as relating to safety outcome,which consists of all-cause mortality (included cardiac death),cardiac arrest,readmission with myocardial infarction and cardiogenic shock

Outcome measures

Measure	Not Low Risk Groups n=42 Participants Patients with modified TIMI\>0 and modified HEART\>2 were considered as high risk for 30-day MACE. Modified TIMI and HEART scores included hs-cTnT tests as opposed to conventional cTnT in the original tests. The presence of any ST-deviation of \>0.05mV in the initial ECG was considered a positive result. A negative hs-cTnT result was defined as a concentration of ≤14ng/L.	Low Risk Group Patients with modified TIMI=0 or modified HEART\<=2 were considered as low risk for 30-day MACE. Modified TIMI and HEART scores included hs-cTnT tests as opposed to conventional cTnT in the original tests. The presence of any ST-deviation of \>0.05mV in the initial ECG was considered a positive result. A negative hs-cTnT result was defined as a concentration of ≤14ng/L.
Number of Safety Major Adverse Cardiac Event	31 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 days

Population: Patient had MACE within 3 months of initial presentation for chest pain in ED

Outcome is the number of patients with effecacy MACE within 30 days after initial ED presentation. Effecacy MACE consists of revascularization (e.g.coronary artery bypass grafting),ventricular arrhythmia needing intervention and high-degree atrioventricular block needing intervention.

Outcome measures

Measure	Not Low Risk Groups n=42 Participants Patients with modified TIMI\>0 and modified HEART\>2 were considered as high risk for 30-day MACE. Modified TIMI and HEART scores included hs-cTnT tests as opposed to conventional cTnT in the original tests. The presence of any ST-deviation of \>0.05mV in the initial ECG was considered a positive result. A negative hs-cTnT result was defined as a concentration of ≤14ng/L.	Low Risk Group Patients with modified TIMI=0 or modified HEART\<=2 were considered as low risk for 30-day MACE. Modified TIMI and HEART scores included hs-cTnT tests as opposed to conventional cTnT in the original tests. The presence of any ST-deviation of \>0.05mV in the initial ECG was considered a positive result. A negative hs-cTnT result was defined as a concentration of ≤14ng/L.
Number of Effecacy MACE	26 Participants	0 Participants

Adverse Events

Not Low Risk Group

Serious events: 26 serious events

Other events: 9 other events

Deaths: 5 deaths

Low Risk Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Not Low Risk Group n=479 participants at risk Patients with modified TIMI\>0 and modified HEART\>2 were considered as high risk for 30-day MACE.	Low Risk Group n=123 participants at risk Patients with modified TIMI=0 or modified HEART\<=2 were considered as low risk for 30-day MACE.
Cardiac disorders Safety MACE (STEMI)	2.1% 10/479 • Number of events 10 • 30 days Major adverse cardiac events encompass both safety and effecacy elements. Safety outcomes consist of all-cause mortality (including cardiac death), cardiac arrest, myocardial infarction and cardiogenic shock. Effecacy outcomes consist of revascularization (e.g. coronary artery bypass grafting or percutaneous coronary intervention), ventricular arrhythmia needing intervention and high-degree atrioventricular block needing intervention	0.00% 0/123 • 30 days Major adverse cardiac events encompass both safety and effecacy elements. Safety outcomes consist of all-cause mortality (including cardiac death), cardiac arrest, myocardial infarction and cardiogenic shock. Effecacy outcomes consist of revascularization (e.g. coronary artery bypass grafting or percutaneous coronary intervention), ventricular arrhythmia needing intervention and high-degree atrioventricular block needing intervention
Cardiac disorders Safety MACE (NSTEMI)	3.3% 16/479 • Number of events 16 • 30 days Major adverse cardiac events encompass both safety and effecacy elements. Safety outcomes consist of all-cause mortality (including cardiac death), cardiac arrest, myocardial infarction and cardiogenic shock. Effecacy outcomes consist of revascularization (e.g. coronary artery bypass grafting or percutaneous coronary intervention), ventricular arrhythmia needing intervention and high-degree atrioventricular block needing intervention	0.00% 0/123 • 30 days Major adverse cardiac events encompass both safety and effecacy elements. Safety outcomes consist of all-cause mortality (including cardiac death), cardiac arrest, myocardial infarction and cardiogenic shock. Effecacy outcomes consist of revascularization (e.g. coronary artery bypass grafting or percutaneous coronary intervention), ventricular arrhythmia needing intervention and high-degree atrioventricular block needing intervention

Other adverse events

Measure	Not Low Risk Group n=479 participants at risk Patients with modified TIMI\>0 and modified HEART\>2 were considered as high risk for 30-day MACE.	Low Risk Group n=123 participants at risk Patients with modified TIMI=0 or modified HEART\<=2 were considered as low risk for 30-day MACE.
Surgical and medical procedures Effectiveness MACE (PCI)	1.5% 7/479 • Number of events 7 • 30 days Major adverse cardiac events encompass both safety and effecacy elements. Safety outcomes consist of all-cause mortality (including cardiac death), cardiac arrest, myocardial infarction and cardiogenic shock. Effecacy outcomes consist of revascularization (e.g. coronary artery bypass grafting or percutaneous coronary intervention), ventricular arrhythmia needing intervention and high-degree atrioventricular block needing intervention	0.00% 0/123 • 30 days Major adverse cardiac events encompass both safety and effecacy elements. Safety outcomes consist of all-cause mortality (including cardiac death), cardiac arrest, myocardial infarction and cardiogenic shock. Effecacy outcomes consist of revascularization (e.g. coronary artery bypass grafting or percutaneous coronary intervention), ventricular arrhythmia needing intervention and high-degree atrioventricular block needing intervention
Surgical and medical procedures Effectiveness MACE (CABG)	0.42% 2/479 • Number of events 2 • 30 days Major adverse cardiac events encompass both safety and effecacy elements. Safety outcomes consist of all-cause mortality (including cardiac death), cardiac arrest, myocardial infarction and cardiogenic shock. Effecacy outcomes consist of revascularization (e.g. coronary artery bypass grafting or percutaneous coronary intervention), ventricular arrhythmia needing intervention and high-degree atrioventricular block needing intervention	0.00% 0/123 • 30 days Major adverse cardiac events encompass both safety and effecacy elements. Safety outcomes consist of all-cause mortality (including cardiac death), cardiac arrest, myocardial infarction and cardiogenic shock. Effecacy outcomes consist of revascularization (e.g. coronary artery bypass grafting or percutaneous coronary intervention), ventricular arrhythmia needing intervention and high-degree atrioventricular block needing intervention

Additional Information

Professor Timothy Rainer

Chinese University of Hong Kong

Phone: 00 852 2632 1034

Email: thrainer@cuhk.edu.hk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place