Trial · NCT01756846
Impact on Management of the HEART Risk Score in Chest Pain Patients
NCT01756846, Not applicable, Completed, UMC Utrecht; results first posted 2019-01-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Impact on Management of the HEART Risk Score in Chest Pain Patients. Trials, record NCT01756846. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01756846
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Impact on Management of the HEART Risk Score in Chest Pain Patients
- NCT number
- NCT01756846
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 3,666 participants, actual
- Lead sponsor
- UMC Utrecht
- Conditions
- Chest Pain
- Interventions
- usual care, use of HEART risk score
- First posted
- 2012-12-28
- Last updated
- 2019-01-25
- Results first posted
- 2019-01-25
- Limitations and caveats
- Hesitance to refrain from admission and testing in patients with low scores could explain the low impact on health care costs.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | MACE (Major Adverse Cardiac Events) | 6 weeks | occurrence of major adverse cardiac events (MACE, i.e. acute myocardial infarction (AMI), Percutaneous Coronary Intervention (PCI), Coronary Artery Bypass Grafting (CABG) or death) within 6 weeks after presentation |
| Secondary | Cost-effectiveness (Costs, QoL, QALYs) | 3 months | Information on quality of life (QoL) and costs was collected in 5 of the 9 hospitals. Costs for health care resource use were calculated based on Dutch guidelines and cost tables for hospitals. Different costs were used for academic and general hospitals, and costs were adjusted for inflation by using the consumer price indices provided by Statistics Netherlands. For each patient the costs were calculated based on the observed number and type of health care resources used and the type of hospital (academic/general). Data on resource use were collected for each patient in the 5 hospitals; no data were missing. QoL was derived from the EQ-5D-3L questionnaire, consisting of 5 questions (dimensions) with 3 answers each, from which QoL scores (utility values, 0-1, the higher the better) can be directly derived. Quality-adjusted life-years (scale 0-100, higher the better) were calculated over a period of 3 months, based on the estimated QoL values at 0 weeks, 2 weeks, and 3 months. |
| Other | Gender-related Differences in Risk for MACE | 3 months | with a women-specific questionnaire, we hope to identify risk factors specific for women (pregnancy diabetes/hypertension, Poly Cystic Ovarial Syndrome (PCOS), etc) |
| Other | Pre-specified Subgroup Analyses | 6 weeks | To assess whether the effectiveness and/or safety of using the HEART (history, ecg, age, risk factors, troponin) score (scale 0-10, with higher scores meaning a higher risk on MACEs) is different between specific patient populations, the following pre-specified subgroup analyses will be performed: Age: below and above 62 years of age (median), Gender: Men vs Women, Diabetics vs non-diabetics, Ethnicity: Caucasian vs. other ethnicity. RESULTS: None of the pre-specified subgroup analyses of women, elderly patients, and diabetic patients showed a statistically significantly different effect of HEART care with respect to incidence of MACEs. Ethnicity was unfortunately not possible to analyse due to too much missing data. NB. I am currently not working in the organisation which has the data, and this will not be possible the coming period. Therefore, I cannot provide correct numbers currently on these subgroup analyses, only conclusions. I am sorry for this inconvenience. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | MACE (Major Adverse Cardiac Events) | 6 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Cost-effectiveness (Costs, QoL, QALYs) | 3 months | Cost-effectiveness analysis was performed in 5 of 9 hospitals | years | MEAN |
| OTHER_PRE_SPECIFIED | Gender-related Differences in Risk for MACE | 3 months | |||
| OTHER_PRE_SPECIFIED | Pre-specified Subgroup Analyses | 6 weeks |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| MACE (Major Adverse Cardiac Events) | Usual Care | 405 | Participants | ||
| MACE (Major Adverse Cardiac Events) | HEART Care | 345 | Participants | ||
| Cost-effectiveness (Costs, QoL, QALYs) | Usual Care | 0.16 | 95% Confidence Interval 0.16 to 0.17 | years | |
| Cost-effectiveness (Costs, QoL, QALYs) | HEART Care | 0.17 | 95% Confidence Interval 0.17 to 0.18 | years |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Usual Care | 1,833 | |
| Overall Study | STARTED | HEART Care | 1,833 | |
| Overall Study | COMPLETED | Usual Care | 1,827 | |
| Overall Study | COMPLETED | HEART Care | 1,821 | |
| Overall Study | NOT COMPLETED | Usual Care | 6 | |
| Overall Study | NOT COMPLETED | HEART Care | 12 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Cardiac ischemia | Cardiac disorders | Usual Care | 400 | 1,827 | 400 |
| serious | Cardiac ischemia | Cardiac disorders | HEART Care | 329 | 1,821 | 329 |
| serious | Death | Cardiac disorders | Usual Care | 9 | 1,827 | 9 |
| serious | Death | Cardiac disorders | HEART Care | 5 | 1,821 | 5 |
| serious | Significant stenosis (PCI, CABG, conservative) | Cardiac disorders | Usual Care | 290 | 1,827 | 290 |
| serious | Significant stenosis (PCI, CABG, conservative) | Cardiac disorders | HEART Care | 247 | 1,821 | 247 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Usual Care | 9 | 1,827 |
| Total, all-cause mortality | HEART Care | 5 | 1,821 |
| Total, other adverse events | Usual Care | 0 | 1,827 |
| Total, other adverse events | HEART Care | 0 | 1,821 |
| Total, serious adverse events | Usual Care | 405 | 1,827 |
| Total, serious adverse events | HEART Care | 345 | 1,821 |
Source ClinicalTrials.gov
Papers10
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| HEART Care vs Usual Care: MACE (Major Adverse Cardiac Events) | Trial comparisons |
| HEART Care vs Usual Care: deaths from any cause | Trial comparisons |
| HEART Care vs Usual Care: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01756846
GET https://conductscience.org/api/trials/v1/NCT01756846/registered