Trial Outcomes & Findings for Screening for Chronic Obstructive Pulmonary Disease in Patients With Acute Coronary Syndromes (NCT NCT02324660)

Results Overview

COPD diagnosis confirmed by spirometry

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

137 participants

Primary outcome timeframe

2 months after inclusion

Results posted on

2017-08-07

Participant Flow

From December 2014 to August 2015, 169 acute cornary syndromes patients with smoking history underwent screening procedure in the University Hospital of Ferrara

Participant milestones

Participant milestones
Measure	Patients Undergoing Screening and Spirometry From December 2014 to August 2015, 169 ACS patients with smoking history underwent screening procedure. Screening procedure combined peak expiratory flow rate (PEFR, defined as positive if \<80% of predicted) and respiratory health status questionnaire (RHSQ, defined as positive if \>19.5 points). Overall, 137 (81%) patients received spirometry (final study population)
Overall Study STARTED	169
Overall Study COMPLETED	137
Overall Study NOT COMPLETED	32

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Screening for Chronic Obstructive Pulmonary Disease in Patients With Acute Coronary Syndromes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients Undergoing Screening and Spirometry n=137 Participants
Age, Continuous	65 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	115 Participants n=5 Participants
Region of Enrollment Italy	137 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 months after inclusion

COPD diagnosis confirmed by spirometry

Outcome measures

Outcome measures
Measure	Patients Undergoing Screening and Spirometry n=137 Participants From December 2014 to August 2015, 169 ACS patients with smoking history underwent screening procedure. Screening procedure combined peak expiratory flow rate (PEFR, defined as positive if \<80% of predicted) and respiratory health status questionnaire (RHSQ, defined as positive if \>19.5 points). Overall, 137 (81%) patients received spirometry (final study population)
COPD Diagnosis	39 participants

SECONDARY outcome

Timeframe: 1 year after inclusion

cumulative occurrence of death, myocardial infarction and heart failure

Outcome measures

Outcome measures
Measure	Patients Undergoing Screening and Spirometry n=137 Participants From December 2014 to August 2015, 169 ACS patients with smoking history underwent screening procedure. Screening procedure combined peak expiratory flow rate (PEFR, defined as positive if \<80% of predicted) and respiratory health status questionnaire (RHSQ, defined as positive if \>19.5 points). Overall, 137 (81%) patients received spirometry (final study population)
Cardiac Adverse Events	8 partecipants

SECONDARY outcome

Timeframe: 2 months

percentage of patients admitted to hospital for ACS and with undiagnosed COPD

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year after inclusion

hospital admission for ACS, for bleeding complications, for respiratory failure, for arrhytmias, for pneumonia

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

occurrence of cardiac death

Outcome measures

Outcome data not reported

Adverse Events

Patients Undergoing Screening and Spirometry

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

Gianluca Campo, PI of the study

Azienda Ospedaliera Universitaria di Ferrara

Phone: 0532237079

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place